| 1 |
NCT03731806 |
Not yet recruiting |
Capsule Endoscopy in Newly Diagnosed Patients of Celiac Disease |
|
|
Observational
|
|
- Tazeen Rasheed
- Dow University of Health Sciences
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- Grading of Celiac Disease on Capsule Endoscopy using Bonatto Classification
|
30 |
All |
8 Years to 60 Years (Child, Adult) |
NCT03731806 |
CAP-CELIAC |
|
December 2018 |
November 2019 |
December 2019 |
November 6, 2018 |
November 8, 2018 |
|
- Ruth KM Pauf Civil Hospital
Karachi, Sindh, Pakistan
|
|
| 2 |
NCT03136731 |
Recruiting |
Evidence-based Screening Strategies for Celiac Disease |
|
- Diagnostic Test: Celiac disease antibody screening
|
Observational
|
|
- Katri Kaukinen
- Tampere University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Forthcoming celiac disease diagnosed by current diagnostic criteria
|
3517 |
All |
6 Months to 100 Years (Child, Adult, Older Adult) |
NCT03136731 |
Celiac2017 |
|
November 29, 2017 |
December 31, 2022 |
December 31, 2032 |
May 2, 2017 |
November 30, 2017 |
|
- Tampere University Hospital / Tampere University
Tampere, Finland
|
|
| 3 |
NCT03562221 |
Not yet recruiting |
Prevention of Celiac Disease in Skåne |
- Celiac Disease in Children
|
- Other: Gluten free diet
- Dietary Supplement: Probiotics
- Dietary Supplement: Placebo
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Number of children tested positive for persistent tissue transglutaminase (tTG) autoantibodies, defined as celiac disease autoimmunity
- Number of children diagnosed with celiac disease
|
600 |
All |
4 Months to 4 Months (Child) |
NCT03562221 |
2018/61 |
PreCiSe |
August 1, 2018 |
August 2024 |
August 2027 |
June 19, 2018 |
June 19, 2018 |
|
|
|
| 4 |
NCT03585478 |
Not yet recruiting |
Latiglutenase as a Treatment for Celiac Disease |
|
- Drug: Latiglutenase
- Other: Placebo
|
Interventional
|
Phase 2 |
- Immunogenics, LLC
- National Institutes of Health (NIH)
- National Center for Complementary and Integrative Health (NCCIH)
|
Industry / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Histologic Protection
- Symptom Severity
|
80 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT03585478 |
IMGX003-NCCIH-1721
1R33AT009637-01 |
|
July 2018 |
February 2020 |
May 2020 |
July 13, 2018 |
July 17, 2018 |
|
- Mayo Clinic - 200 First Street SW
Rochester, Minnesota, United States
|
|
| 5 |
NCT03763487 |
Recruiting
New |
The Aim of This Project is to Verify Whether a Depletion of B Cell Memory Subpopulation ("Marginal-zone-like") CD19 + IgD + CD27 + and CD19 + IgM + CD27 + is a Useful Indicator of Hyposplenism in Patients With Celiac Disease |
|
- Diagnostic Test: venous blood sampling
- Procedure: spleen volumetry
|
Interventional
|
Not Applicable |
- University Hospital Hradec Kralove
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- concentration of B-lymphocytes as parameter to evaluate treatment effect
- concentration of citrullin in plasma as parameter to evaluate treatment effect
- concentration of ornithin in plasma as parameter to evaluate treatment effect
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT03763487 |
Indicators of celiac activity |
|
June 1, 2018 |
December 31, 2018 |
December 31, 2018 |
December 4, 2018 |
December 4, 2018 |
|
- University Hospital Hradec Králové
Hradec Králové, The Czech Republic, Czechia
|
|
| 6 |
NCT01172665 |
Unknown † |
Celiac Disease Database |
|
|
Observational
|
|
|
Other |
- Observational Model: Case-Only
|
|
3500 |
All |
up to 70 Years (Child, Adult, Older Adult) |
NCT01172665 |
16103A |
|
September 2008 |
September 2017 |
|
July 30, 2010 |
August 31, 2016 |
|
- The University of Chicago Medical Center
Chicago, Illinois, United States
|
|
| 7 |
NCT03320811 |
Completed |
Interpretation of Serological Tests in the Diagnosis of Celiac Disease: Anti-deamidated Gliadin Peptide Antibodies Revisited |
|
|
Observational
|
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Retrospective
|
|
2026 |
All |
Child, Adult, Older Adult |
NCT03320811 |
2016Ao005 |
DGP-CeliacDis |
January 1, 2015 |
September 1, 2015 |
January 1, 2016 |
October 25, 2017 |
October 25, 2017 |
|
- Damien JOLLY
Reims, France
|
|
| 8 |
NCT02805816 |
Completed |
Choosing a Preferred Serology Kit for Screening and Diagnosis of Celiac Disease |
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Diagnosis of Celiac Disease based on histological findings.
|
128 |
All |
6 Months to 18 Years (Child, Adult) |
NCT02805816 |
0466-15 RMC |
|
June 8, 2016 |
June 2017 |
July 2018 |
June 20, 2016 |
September 7, 2018 |
|
- Schneider children's medical center of Israel
Petach-Tikva, Israel
|
|
| 9 |
NCT03521180 |
Recruiting |
A Study to Evaluate Gluten Challenge on Immune Responses in Subjects With Celiac Disease |
|
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Gut-homing, activated, CD8+ αβ T cells and γδ T cells in PBMC
- Evaluation of Gliadin reactive T cell measures- PBMC (peripheral blood mononuclear cells) by Flow Cytometry
- Gliadin reactive T cell measures- PBMC (peripheral blood mononuclear cells) by ELISPOT
|
15 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03521180 |
NDS-CP-002
U1111-1208-7879 |
|
May 11, 2018 |
February 28, 2019 |
February 28, 2019 |
May 10, 2018 |
December 5, 2018 |
|
- Covance
Dallas, Texas, United States - Virginia Mason Medical Center
Seattle, Washington, United States
|
|
| 10 |
NCT01765647 |
Completed |
Oral AGY for Celiac Disease |
|
|
Interventional
|
Phase 1 |
- Igy Inc.
- University of Alberta
|
Industry / Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- general safety
- Symptoms
- Health Related Quality of Life
- ATG antibody level
|
10 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01765647 |
AGY |
|
May 2014 |
August 2015 |
August 2015 |
January 10, 2013 |
April 21, 2016 |
|
- University of Alberta
Edmonton, Alberta, Canada
|
|
| 11 |
NCT01909050 |
Completed |
Immune Response in Celiac Disease on In-vitro Gluten Challenge |
|
|
Observational
|
|
- Beth Israel Deaconess Medical Center
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- change in interferon gamma
- change in interleukin-15
- change in interleukin-18
- change in interleukin-21
|
42 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01909050 |
2012P000354 |
|
February 2013 |
January 2018 |
March 2018 |
July 26, 2013 |
March 19, 2018 |
|
- Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
|
|
| 12 |
NCT01661933 |
Completed
Has Results |
Desensitising Celiac Disease Patients With the Human Hookworm |
|
- Biological: Necator americanus
|
Interventional
|
Phase 1
Phase 2 |
- The Prince Charles Hospital
- National Health and Medical Research Council, Australia
|
Other |
- Intervention Model: Single Group Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Duodenal Villus Height:Crypt Depth
- Intraepithelial Lymphocyte Count
- Number of Participants With 2 Points Increase in Marsh Score Post GC-1g
- Serum Anti-tissue Transglutaminase Antibodies Measured as International Units/mL (IU/mL)
|
12 |
All |
18 Years and older (Adult, Older Adult) |
NCT01661933 |
AU/3/BOBD012 |
NaCeD |
August 2012 |
March 2014 |
March 2014 |
August 10, 2012 |
October 20, 2014 |
October 13, 2014 |
- Prince Charles Hospital
Chermside, Queensland, Australia
|
|
| 13 |
NCT03486990 |
Active, not recruiting |
Study of the Safety, Tolerability and Pharmacokinetics of TIMP-GLIA in Subjects With Celiac Disease |
|
|
Interventional
|
Phase 1 |
- COUR Pharmaceutical Development Company, Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Treatment-Emergent Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 as a Measure of Safety and Tolerability of TIMP-GLIA
- Pharmacokinetics of TIMP-GLIA in plasma: Cmax
- Pharmacokinetics of TIMP-GLIA in plasma: Tmax
- (and 5 more...)
|
22 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03486990 |
TGLIA-5.001 |
|
February 9, 2018 |
November 2018 |
March 2019 |
April 3, 2018 |
November 12, 2018 |
|
- Jacksonville Center For Clinical Research
Jacksonville, Florida, United States - Mass General Hospital Translational and Clinical Research Centers
Boston, Massachusetts, United States - Mayo Gastroenterology Research Unit
Rochester, Minnesota, United States - Prism Clinical Research
Saint Paul, Minnesota, United States
|
|
| 14 |
NCT02242123 |
Recruiting |
Celiac Disease Diagnosis in Patients With Weakly Positive Serum Anti-Transglutaminase: Duodenal Anti-Endomysium Assay. |
|
|
Observational
|
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Changes in the intestinal histology of the patients with clinically suspected CD and weakly positive [e.g. 2-3xN] serum anti-tTG antibodies, at the time of the first evaluation.
- Serum IgA anti-tTG antibodies evaluation.
- Symptoms/signs evaluation.
|
50 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02242123 |
ACPM05 |
|
January 2012 |
December 2016 |
June 2019 |
September 16, 2014 |
September 5, 2018 |
|
- Internal Medicine Department of the Hospital of Sciacca (Agrigento)
Sciacca, Agrigento, Italy - Internal Medicine Department of the University Hospital of Palermo
Palermo, Italy
|
|
| 15 |
NCT01917630 |
Unknown † |
Evaluation of the Efficacy and Safety of ALV003 in Symptomatic in Celiac Disease Patients |
|
- Drug: ALV003
- Drug: placebo
|
Interventional
|
Phase 2 |
- Alvine Pharmaceuticals Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Efficacy: Intestinal mucosal morphometry
- Efficacy: Intestinal intraepithelial lymphocyte density
- Safety: safety and tolerability of ALV003
|
500 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT01917630 |
ALV003-1221 |
|
August 2013 |
April 2015 |
June 2015 |
August 7, 2013 |
December 17, 2014 |
|
- Decatur, Alabama, United States
- Huntsville, Alabama, United States
- Huntsville, Alabama, United States
- (and 85 more...)
|
|
| 16 |
NCT02061306 |
Recruiting |
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study |
|
|
Observational
|
|
- Massachusetts General Hospital
- University of Roma La Sapienza
- Università Politecnica delle Marche
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in composition of the microbiota of CD in at-risk infants using culture-independent high-throughput sequence analysis of the 16S rRNA genes using the Illumina sequencing platform.
- Change in gut permeability measured by serum zonulin levels and loss of gluten tolerance measured by increased expression of pro-inflammatory cytokines and appearance of anti-tTg antibodies.
|
400 |
All |
up to 6 Months (Child) |
NCT02061306 |
2013P001965 |
CDGEMM |
March 2014 |
December 2024 |
December 2024 |
February 12, 2014 |
August 15, 2018 |
|
- Massachusetts General Hospital for Children
Boston, Massachusetts, United States - University of Roma La Sapienza
Rome, Italy
|
|
| 17 |
NCT02220166 |
Completed |
Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease |
|
- Dietary Supplement: Triticum monococcum
|
Interventional
|
Phase 2 |
- Università degli Studi di Brescia
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Histologic: 4 duodenal biopsies obtained and classified according to Marsh
- Clinical: Change in Gastrointestinal Symptom Rating Scale (GSRS)
|
8 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02220166 |
GE-GA2-2010 |
|
November 2010 |
July 2011 |
August 2011 |
August 19, 2014 |
August 19, 2014 |
|
- AO Spedali Civili of Brescia
Brescia, Italy
|
|
| 18 |
NCT02464150 |
Recruiting |
Gluten Challenge in Celiac Disease |
|
- Dietary Supplement: Gluten challenge
|
Interventional
|
Not Applicable |
- Oslo University Hospital
- Stiftelsen Helse og Rehabilitering
- Helse Sor-Ost
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Transcriptome of gluten-specific T cells
|
10 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT02464150 |
2013/1237 |
|
April 1, 2017 |
April 2018 |
June 2018 |
June 8, 2015 |
May 30, 2017 |
|
- Oslo university hospital - Rikshospitalet
Oslo, Norway
|
|
| 19 |
NCT02637141 |
Completed |
A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease |
|
- Biological: AMG 714
- Biological: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Attenuation of gluten-induced small intestinal mucosal injury as assessed by the change from baseline to Week 12 in Vh:Cd ratio
- Attenuation of gluten-induced small intestinal mucosal inflammation at Week 12 compared to baseline, as measured by the enumeration of intraepithelial lymphocytes (IELs) in histological sections
- Attenuation of gluten-induced serum antibodies at Week 12 compared to baseline (anti-deamidated gliadin peptides, DGP) and autoantibodies (anti-transglutaminase, ATG)
- Attenuation at Week 12 compared to baseline, of gluten-induced clinical symptoms as measured by the Gastrointestinal Symptom Rating Scale (GSRS)
|
64 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02637141 |
CELIM-NRCD-001
2015-003647-19 |
|
March 9, 2016 |
February 15, 2017 |
March 14, 2017 |
December 22, 2015 |
February 1, 2018 |
|
- ODL
Oulu, Finland - Tampere University Hospital
Tampere, Finland - CRST
Turku, Finland
|
|
| 20 |
NCT01129908 |
Completed |
Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet |
|
|
Observational
|
|
- Hadassah Medical Organization
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
90 |
All |
3 Years to 18 Years (Child, Adult) |
NCT01129908 |
odelia- HMO-CTIL |
|
May 2010 |
July 2012 |
July 2012 |
May 25, 2010 |
December 20, 2016 |
|
|
|
| 21 |
NCT01257620 |
Completed |
Clinical Trial on the Effects of Bifidobacterium Infantis in Active Celiac Disease |
|
- Dietary Supplement: Probiotic
|
Interventional
|
Not Applicable |
- Bai, Julio M.D.
- The National Institute of Probiotics
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Intestinal permeability changes
- Changes in the cytokine profile.
|
22 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01257620 |
Celiac |
Celiac |
December 2010 |
September 2011 |
December 2011 |
December 10, 2010 |
February 13, 2012 |
|
- Dr. C. Bonorino Udanondo Gastroenterology Hospital
Buenos Aires, Argentina
|
|
| 22 |
NCT03271138 |
Completed |
Bifidobacterium Infantis NLS Super Strain for Celiac Disease Patients on a Gluten-free Diet With Persistent Gastrointestinal Symptoms |
|
- Dietary Supplement: Bifidobacterium infantis NLS super strain (Natren LIFE START®2)
- Other: Placebo
|
Interventional
|
Phase 2 |
- Global Institute of Probiotics
- Dr. C. Bonorino Udaondo Gastroenterology Hospital
- Research Institute, Universidad del Salvador
- Consejo de Investigaciones en Salud, Ministerio de Salud, Gobierno Autónomo de Buenos Aires
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Changes in Gastrointestinal Symptom Rating Scale (GSRS)
- Changes in Celiac Symptoms Index (CSI)
- Changes in Quality of Life: SF-36
- (and 4 more...)
|
18 |
All |
18 Years and older (Adult, Older Adult) |
NCT03271138 |
GlobalIP
001 |
|
July 21, 2017 |
December 7, 2017 |
December 7, 2017 |
September 1, 2017 |
August 24, 2018 |
|
- Small Bowel Section, Department of Medicine, Dr. C. Bonorino Udaondo Gastroenterology Hospital
Buenos Aires, Argentina
|
|
| 23 |
NCT03520244 |
Completed |
A 12-week Exercise Program for Adults With Celiac Disease |
|
- Behavioral: Exercise + Holistic Education
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Celiac Disease Quality of Life (CD-QoL)
- Microbiome
- Adherence to a Gluten-free Diet
- (and 10 more...)
|
48 |
All |
18 Years and older (Adult, Older Adult) |
NCT03520244 |
REB16-1774 |
MOVE-C |
November 15, 2016 |
March 30, 2018 |
March 30, 2018 |
May 9, 2018 |
September 28, 2018 |
|
- University of Calgary
Calgary, Alberta, Canada
|
|
| 24 |
NCT01695681 |
Unknown † |
Screen-detected Coeliac Disease, a Population Based Study |
|
|
Interventional
|
Not Applicable |
- University Hospital of North Norway
- The Norwegian Coeliac Society
- The Gastrointestinal Research Foundation, University Hospital of NorthNorway
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Gastrointestinal symptoms
- Quality of Life
|
200 |
All |
30 Years to 87 Years (Adult, Older Adult) |
NCT01695681 |
2011/1943 (REK) |
|
October 2012 |
September 2017 |
September 2017 |
September 28, 2012 |
November 29, 2016 |
|
- University hospital of North Norway
Tromsoe, Norway
|
|
| 25 |
NCT03364556 |
Completed |
Nutritional Intake and Bone Health in Celiac Disease |
|
|
Observational
|
|
|
Other |
- Observational Model: Other
- Time Perspective: Cross-Sectional
|
- Dietary Intake
- Bone Mineral Density
|
13893 |
All |
18 Years and older (Adult, Older Adult) |
NCT03364556 |
1159415 |
|
June 2016 |
November 2017 |
November 2017 |
December 6, 2017 |
December 6, 2017 |
|
|
|
| 26 |
NCT03409796 |
Recruiting |
Assessment of Immune Activation and Tolerance in Celiac Disease |
|
- Dietary Supplement: Gluten
|
Interventional
|
Early Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Other
|
- Change From Baseline in Small Intestine Histology
- Correlation Coefficient Between Gluten-specific Blood T Cells and Standard CeD Histological Assessments
- Change From Baseline in Blood T Cells After Gluten Challenge
|
20 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03409796 |
TIMP-GLIA-5001
U1111-1202-6708 |
|
April 24, 2018 |
January 28, 2019 |
January 28, 2019 |
January 24, 2018 |
November 19, 2018 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States - Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
|
|
| 27 |
NCT01045837 |
Completed |
Effect of Addition of Short Course of Prednisolone to Gluten Free Diet in Naive Celiac Disease Patients |
|
- Drug: Prednisolone and Gluten free diet
- Behavioral: Gluten free diet
|
Interventional
|
Phase 2
Phase 3 |
- All India Institute of Medical Sciences, New Delhi
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients having improvement in symptoms at 4 weeks
- Proportion of patients having improvement in histological improvement by at least one grade at 4 weeks
- Proportion of patients showing normalization of histological abnormalities at 6 months
|
33 |
All |
12 Years and older (Child, Adult, Older Adult) |
NCT01045837 |
Celiac-Prednisolone |
CD |
April 2009 |
April 2010 |
August 2010 |
January 11, 2010 |
January 19, 2012 |
|
- All India Institute of Medical Sciences
New Delhi, Delhi, India
|
|
| 28 |
NCT01902368 |
Terminated |
Celiac Disease Screening |
|
|
Interventional
|
Not Applicable |
- Beth Israel Deaconess Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Screening
|
- change in health related quality of life
- change in celiac symptoms
- change in bone density
- (and 2 more...)
|
14 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT01902368 |
2012P000326 |
|
September 2013 |
April 2014 |
August 2014 |
July 18, 2013 |
March 19, 2018 |
|
- Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
|
|
| 29 |
NCT01560169 |
Completed |
Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients |
|
|
Observational
|
|
- Alvine Pharmaceuticals Inc.
|
Industry |
- Time Perspective: Prospective
|
- Change in symptoms using patient reported outcome instruments
- Safety - incidence of adverse events
|
110 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT01560169 |
ALV003-1121 |
|
March 2012 |
September 2013 |
September 2013 |
March 22, 2012 |
October 10, 2013 |
|
- University of California, San Diego
La Jolla, California, United States - Kaiser Permanente Southern California, Allergy Department
San Diego, California, United States - University of Colorado, Denver
Aurora, Colorado, United States - (and 7 more...)
|
|
| 30 |
NCT03707730 |
Not yet recruiting |
A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease |
|
- Dietary Supplement: AGY
- Other: placebo
|
Interventional
|
Phase 2 |
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
149 |
All |
10 Years to 65 Years (Child, Adult, Older Adult) |
NCT03707730 |
AGY-010 |
AGY-010 |
December 2018 |
December 2022 |
December 2022 |
October 16, 2018 |
October 17, 2018 |
|
|
|
| 31 |
NCT03738475 |
Not yet recruiting |
Study of the Safety, Pharmacodynamics, Efficacy, and PK of TIMP-GLIA in Subjects With Celiac Disease |
|
- Drug: TIMP-GLIA
- Drug: Placebo
|
Interventional
|
Phase 2 |
- COUR Pharmaceutical Development Company, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- IFN-γ spot forming units
- Villus height to crypt depth ratio (Vh:Cd)
- Intestinal intraepithelial lymphocytes (IELs)
- (and 4 more...)
|
30 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03738475 |
TGLIA-5.002 |
|
December 2018 |
May 2019 |
May 2019 |
November 12, 2018 |
November 12, 2018 |
|
|
|
| 32 |
NCT03095573 |
Recruiting |
Comparison Between Axial- and Lateral-viewing Capsule Endoscopy in Celiac Disease |
|
- Device: Lateral-viewing CapsoCam device
- Device: Axial-viewing capsule
|
Interventional
|
Not Applicable |
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- IRCCS Policlinico S. Donato
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Diagnostic
|
- Lesions detected
- Extension of the lesions
|
25 |
All |
18 Years and older (Adult, Older Adult) |
NCT03095573 |
Capsocam |
|
March 1, 2017 |
October 31, 2018 |
February 28, 2019 |
March 29, 2017 |
March 30, 2017 |
|
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano, MI, Italy - Irccs Policlinico San Donato
San Donato Milanese, MI, Italy
|
|
| 33 |
NCT02472119 |
Unknown † |
Wheat Flour Treatment With Microbial Transglutaminase and Lysine Ethyl Ester: New Frontiers in Celiac Disease Treatment. |
|
- Dietary Supplement: rusks made of wheat flour enzymatically treated
- Dietary Supplement: rusks made of wheat flour not enzimatically modified
- Dietary Supplement: Gluten-free diet
|
Interventional
|
Phase 2 |
- University of Roma La Sapienza
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change from baseline in IgA anti-tissue transglutaminase (anti-tTG) antibodies at 30 days
- Change from baseline in IgA anti-tissue transglutaminase (anti-tTG) antibodies at 60 days
- Change from baseline in IgA anti-tissue transglutaminase (anti-tTG) antibodies at 90 days
- (and 20 more...)
|
20 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02472119 |
672/10 Rif. 1907 / 22.07.2010 |
WHETMIT |
June 2015 |
August 2015 |
August 2015 |
June 15, 2015 |
June 15, 2015 |
|
- Sapienza University - Policlinico Umberto I
Rome, Italy
|
|
| 34 |
NCT03569007 |
Not yet recruiting |
Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Treatment of Celiac Disease |
|
- Drug: Larazotide Acetate
- Drug: Matching Placebo
|
Interventional
|
Phase 3 |
- Innovate Biopharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Proportion of subjects who are binary responders
|
924 |
All |
18 Years and older (Adult, Older Adult) |
NCT03569007 |
CeD-LA-3001 |
|
October 2018 |
June 2020 |
December 2020 |
June 25, 2018 |
August 31, 2018 |
|
|
|
| 35 |
NCT03176095 |
Completed |
Celiac Disease Prevention With Probiotics |
- Celiac Disease in Children
|
- Dietary Supplement: Probiotic
- Dietary Supplement: Placebo
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Tissue transglutaminase autoantibodies (tTGA)
|
90 |
All |
2 Years to 12 Years (Child) |
NCT03176095 |
2011/335 |
CiPP |
March 1, 2012 |
August 30, 2015 |
August 30, 2015 |
June 5, 2017 |
June 16, 2017 |
|
|
|
| 36 |
NCT03152279 |
Enrolling by invitation |
Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance |
|
- Diagnostic Test: Mucosal Impedance Catheter
- Diagnostic Test: Blood sample
|
Observational
|
|
- Vanderbilt University Medical Center
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- mucosal impedance values
- Marsh Score
- IFABP
|
50 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT03152279 |
161436 |
|
December 2016 |
December 2018 |
December 2018 |
May 15, 2017 |
January 18, 2018 |
|
- Vanderbilt University Medical Center Endoscopy Laboratory
Nashville, Tennessee, United States
|
|
| 37 |
NCT03168490 |
Recruiting |
In Vivo Effects of the Gluten Friendly Bread in Coeliac Disease |
|
- Dietary Supplement: Gluten Friendly bread
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- The cellular and molecular basis for modulation of immune function by GLUTEN FRIENDLY BREAD
- The modulation of the gut microbiota by gluten friendly bread
|
60 |
All |
20 Years to 80 Years (Adult, Older Adult) |
NCT03168490 |
LSC 15/146 |
|
February 1, 2016 |
January 20, 2018 |
April 1, 2018 |
May 30, 2017 |
May 30, 2017 |
|
- Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, United Kingdom
|
|
| 38 |
NCT00669825 |
Completed |
Study of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease Following a Gluten-Containing Meal |
|
- Drug: ALV003
- Drug: Placebo
|
Interventional
|
Phase 1 |
- Alvine Pharmaceuticals Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Participant)
- Primary Purpose: Basic Science
|
|
36 |
All |
18 Years to 45 Years (Adult) |
NCT00669825 |
ALV003-0812 |
FED |
March 2008 |
October 2008 |
October 2008 |
May 1, 2008 |
February 19, 2010 |
|
- Clinical Applications Laboratories, Inc.
San Diego, California, United States - Clinical Applications Laboratories
San Diego, California, United States
|
|
| 39 |
NCT00626184 |
Completed |
A Phase 1, Study of the Safety and Tolerability of ALV003 in Healthy Adult Volunteers and Subjects With Well-Controlled Celiac Disease |
|
- Drug: 4 dose levels of ALV003
|
Interventional
|
Phase 1 |
- Alvine Pharmaceuticals Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
|
28 |
All |
18 Years to 45 Years (Adult) |
NCT00626184 |
ALV003-0811 |
|
February 2008 |
May 2008 |
July 2008 |
February 29, 2008 |
August 18, 2009 |
|
- Clinical Applications Laboratories Inc.
San Diego, California, United States
|
|
| 40 |
NCT03321214 |
Not yet recruiting |
Gluten Sensor Device to Promote Gluten Free Diet Adherence and Quality of Life in Patients With Celiac Disease |
|
- Device: Gluten Sensor Device
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Quality of life measure
- Depression
- Adherence to the gluten-free diet
- (and 2 more...)
|
30 |
All |
13 Years to 65 Years (Child, Adult, Older Adult) |
NCT03321214 |
AAAR6004 |
|
December 1, 2017 |
June 1, 2018 |
December 1, 2018 |
October 25, 2017 |
October 30, 2017 |
|
- Celiac Disease Center at Columbia University
New York, New York, United States
|
|
| 41 |
NCT02675283 |
Completed |
Case Finding for Coeliac Disease Using a Point of Care Test in a Pharmacy Setting |
|
|
Interventional
|
Not Applicable |
- Sheffield Teaching Hospitals NHS Foundation Trust
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- The prevalence of CD in this study cohort as a result of a case finding approach using a POCT in a pharmacy setting.
- The proportion of individuals agreeing to fill in the eligibility questionnaire.
- The proportion of individuals undertaking the POCT.
- The proportion of individuals undergoing a gastroscopy with duodenal biopsies.
|
502 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT02675283 |
STH19172 |
|
July 2016 |
October 2017 |
October 2017 |
February 5, 2016 |
November 24, 2017 |
|
- Sheffield Teaching Hospitals
Sheffield, United Kingdom
|
|
| 42 |
NCT02834429 |
Completed |
Pre-endoscopy Serological Testing for Coeliac Disease; a Novel Approach Using Rapid Antibody Testing |
|
|
Observational
|
|
- Sheffield Teaching Hospitals NHS Foundation Trust
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Positive and negative predictive values of the whole blood transglutaminase-based rapid test tissue for diagnosing coeliac disease
|
1596 |
All |
18 Years and older (Adult, Older Adult) |
NCT02834429 |
STH15416 |
|
February 2010 |
August 2017 |
October 2017 |
July 15, 2016 |
November 24, 2017 |
|
- Department of Gastroenterology
Sheffield, South Yorkshire, United Kingdom
|
|
| 43 |
NCT03064997 |
Completed |
Prebiotic as a Supplement of Gluten-free Diet in the Management of Celiac Disease in Children |
|
- Dietary Supplement: Synergy 1
- Dietary Supplement: Placebo
|
Interventional
|
Not Applicable |
- Polish Academy of Sciences
- University of Warmia and Mazury
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Assessment of the intestinal permeability
- Assessment of the advers events
- Analysis of the concentration of the short chain fatty acids (SCFAs)
- Molecular characteristic of faecal microbiota
|
34 |
All |
3 Years to 18 Years (Child, Adult) |
NCT03064997 |
IAR&FR internal project 20 |
|
January 12, 2016 |
March 1, 2016 |
June 1, 2016 |
February 27, 2017 |
February 27, 2017 |
|
- Regional Specialized Children'S Hospital
Olsztyn, Poland - Institute of Animal Reproduction and Food Research, Polish Academy of Sciences in Olsztyn
Olsztyn, Poland
|
|
| 44 |
NCT01255696 |
Completed |
Safety and Efficacy of Varying Methods of ALV003 Administration for the Treatment of Celiac Disease |
|
- Biological: ALV003
- Biological: ALV003 placebo
|
Interventional
|
Phase 2 |
- Alvine Pharmaceuticals Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Efficacy: Intestinal mucosal morphology
- Safety: Tolerability of ALV003
- Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype
- Efficacy: Change in serological markers of celiac disease
|
61 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01255696 |
ALV003-1021
2010-023127-23 |
|
November 2010 |
May 2011 |
June 2011 |
December 7, 2010 |
August 6, 2012 |
|
- Terveystalo Kuopio
Kuopio, Finland - Oulu Diakonissalaitos (ODL)
Oulu, Finland - FINN-MEDI Research Oy - Clinical Trials Center
Tampere, Finland
|
|
| 45 |
NCT00617838 |
Unknown † |
Celiac Disease Prevention |
|
- Other: Optimal gluten introduction
|
Interventional
|
Not Applicable |
- Kuopio University Hospital
- University of Eastern Finland
- University of Turku
- (and 3 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- development of transglutaminase antibodies
- gliadin peptide antibodies
- mucosal biopsy in TGA positive childre
|
168 |
All |
up to 2 Months (Child) |
NCT00617838 |
KUH5021612 |
|
October 2007 |
August 2014 |
December 2014 |
February 18, 2008 |
August 23, 2013 |
|
- Kuopio University Hospital
Kuopio, Finland
|
|
| 46 |
NCT02475369 |
Enrolling by invitation |
Pancreatic Enzyme Supplementation for Celiac Disease |
|
|
Interventional
|
Phase 4 |
- Beth Israel Deaconess Medical Center
- Actavis Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- reduction of gastrointestinal symptoms
- fecal elastase measurement
|
14 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT02475369 |
2014P000375 |
|
May 2015 |
June 2019 |
December 2019 |
June 18, 2015 |
October 11, 2018 |
|
- Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
|
|
| 47 |
NCT02754609 |
Active, not recruiting |
Hookworm Therapy for Coeliac Disease |
|
- Other: Gluten micro-challenge
- Other: Inadvertent gluten challenge
- Other: Moderate gluten challenge
- (and 5 more...)
|
Interventional
|
Phase 1 |
- James Cook University, Queensland, Australia
- Townsville Hospital
- The Prince Charles Hospital
- (and 5 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Difference in V:C ratio between baseline (week -2) and week 36
- Difference in mucosal intraepithelial lymphocyte count between baseline (week -2) and week 12
- Difference in mucosal intraepithelial lymphocyte count between baseline (week -2) and week 42
- (and 14 more...)
|
60 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT02754609 |
CT-2016-CTN-01363-1 |
NainCeD-3 |
September 2016 |
December 2020 |
December 2020 |
April 28, 2016 |
March 12, 2018 |
|
- Prince Charles Hospital
Brisbane, Queensland, Australia - Logan Hospital
Logan, Queensland, Australia - Townsville Hospital
Townsville, Queensland, Australia - Christchurch Hospital
Christchurch, New Zealand
|
|
| 48 |
NCT01439035 |
Completed
Has Results |
Evaluate the Use of Optical Frequency Domain Imaging (OFDI) for Celiac Disease in Children, Adolescents and Young Adults |
|
|
Interventional
|
Not Applicable |
- Massachusetts General Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging
|
6 |
All |
7 Years and older (Child, Adult, Older Adult) |
NCT01439035 |
2009-P-000938 |
|
August 2009 |
February 4, 2010 |
February 4, 2011 |
September 22, 2011 |
October 24, 2018 |
September 26, 2018 |
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
|
| 49 |
NCT00959114 |
Completed |
Safety and Efficacy of ALV003 for the Treatment of Celiac Disease |
|
- Biological: ALV003
- Biological: ALV003 placebo
|
Interventional
|
Phase 2 |
- Alvine Pharmaceuticals Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Efficacy: Intestinal mucosal morphology
- Safety: Tolerability of ALV003
- Efficacy: Change in intestinal intraepithelial lymphocyte numbers/phenotype
- Efficacy: Change in serological markers of celiac disease
|
74 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT00959114 |
ALV003-0921 |
|
August 2009 |
August 2010 |
October 2010 |
August 14, 2009 |
August 6, 2012 |
|
- FINN-MEDI Research - Clinical Trials Center
Tampere, Finland
|
|
| 50 |
NCT02244047 |
Completed |
Cytokine Profile in Children With Celiac Disease |
|
- Drug: Bifidobacterium breve
- Drug: Placebo (for Bifidobacterium breve)
|
Interventional
|
Phase 1
Phase 2 |
- University Clinical Centre, Maribor
- Slovenian Research Agency
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- Serum TNF-alpha decrease after Bifidobacterium breve daily consumption in children with celiac disease
|
66 |
All |
1 Year to 18 Years (Child, Adult) |
NCT02244047 |
CEL-BIF |
|
October 2013 |
June 2014 |
June 2014 |
September 18, 2014 |
September 18, 2014 |
|
|
|
| 51 |
NCT02458898 |
Completed |
Text Message Intervention to Improve Adherence in Adolescents and Young Adults With Celiac Disease |
|
- Behavioral: Educational Text Message Reminders
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- Tissue Transglutaminase IgA (TTG IgA)
- Deamidated Gliadin Peptide IgA (DGP IgA)
- NIH-PROMIS quality of life score
- (and 3 more...)
|
61 |
All |
12 Years to 24 Years (Child, Adult) |
NCT02458898 |
29967 |
|
February 2015 |
May 2016 |
May 2016 |
June 1, 2015 |
May 27, 2016 |
|
- Stanford University Pediatric Gastroenterology Department
Palo Alto, California, United States
|
|
| 52 |
NCT02528799 |
Completed |
Safety and Tolerability of Nexvax2 in Subjects With Celiac Disease |
|
- Biological: Nexvax2
- Biological: Nexvax2 placebo
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Incidence of toxicity and safety of Nexvax2 according to the "Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0"
- Weekly Gastrointestinal Symptom Rating Scale (GSRS)
- Plasma Cytokine Levels
|
38 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02528799 |
Nexvax2-1004
U1111-1173-7522 |
|
August 2015 |
January 6, 2017 |
January 6, 2017 |
August 19, 2015 |
April 21, 2017 |
|
- Q-Pharm Pty Ltd.
Herston, Queensland, Australia - CMAX, A Division of IDT Australia Ltd
Adelaide, South Australia, Australia - Linear Clinical Research
Nedlands, Australia - Auckland Clinical Studies Ltd
Auckland, New Zealand
|
|
| 53 |
NCT02679014 |
Completed |
A Study to Investigate the Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Repeated Dosing of RO5459072 in Volunteers With Celiac Disease |
|
- Drug: Placebo
- Drug: RO5459072
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Overall Numbers of Participants who are Responders to the Gluten Challenge, Defined as Participants with an Increase in Number of Gliadin Specific T-cells Above Assay-Specific Thresholds
- Percentage of Participants with Adverse Events (AEs)
- Number of Participants with an Increase in Antibody Titers (Anti-Tissue Transglutaminase [anti-tTG] Immunoglobulin A [IgA] and Immunoglobulin G [IgG] and Anti-Deamidated Gliadin Peptide (anti-DPG) IgA), as Determined Using Enzyme Immunoassay Methods
- (and 8 more...)
|
19 |
All |
18 Years to 60 Years (Adult) |
NCT02679014 |
BP29911
2015-002864-18 |
|
March 6, 2016 |
August 28, 2016 |
August 28, 2016 |
February 10, 2016 |
August 25, 2017 |
|
- Hammersmith Medicines Research Ltd.
London, United Kingdom
|
|
| 54 |
NCT01116505 |
Completed |
Treatment of Screen-detected Celiac Disease |
|
- Dietary Supplement: Gluten-free diet
|
Interventional
|
Not Applicable |
- Tampere University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Small-bowel mucosal morphology and inflammation
- Endomysial antibodies
- Tissue transglutaminase antibodies
- (and 6 more...)
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT01116505 |
R07122 |
|
August 2008 |
July 2012 |
August 2012 |
May 5, 2010 |
August 27, 2012 |
|
- Pediatric Research Centre, Tampere University Hospital and University of Tampere
Tampere, Pirkanmaa, Finland
|
|
| 55 |
NCT01145287 |
Completed |
Impact of the Diagnosis of Celiac Disease |
|
|
Observational
|
|
- Tampere University Hospital
- University of Tampere
- Finnish Celiac Society
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Psychological General Well-Being (PGWB) Index
- healthcare resource utilization
- Gastrointestinal Symptoms Rating Scale (GSRS)
- (and 4 more...)
|
760 |
All |
Child, Adult, Older Adult |
NCT01145287 |
Burden-1 |
|
February 2007 |
April 2016 |
April 2016 |
June 16, 2010 |
April 21, 2016 |
|
- Pediatric Research Centre, University of Tampere, Tampere University Hospital
Tampere, Pirkanmaa, Finland
|
|
| 56 |
NCT01338324 |
Completed |
Protocol for Correlating Enteropathic Severity and Small Intestinal CYP3A4 Activity in Patients With Celiac Disease |
|
|
Interventional
|
Phase 2
Phase 3 |
- All India Institute of Medical Sciences, New Delhi
- University of Zurich
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Maximum serum concentration (Cmax ) of simvastatin (20 mg, orally dosed after fasting) in subjects with celiac sprue
- Duodenal level of cytochrome CYP3A4
|
41 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01338324 |
N-1229 |
Cyp |
April 2010 |
June 2011 |
September 2011 |
April 19, 2011 |
December 13, 2011 |
|
- All India Institute of Medical Sciences
New Delhi, Delhi, India
|
|
| 57 |
NCT01975155 |
Unknown † |
Dietary Assessment and Mycotoxin Exposure in Celiac Disease |
|
- Other: food questionnaire
- Other: Urinary mycotoxin test
|
Observational
|
|
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- University of Parma
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Mycotoxins
- dietary questionnaire
|
100 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT01975155 |
852/12
GFD/2012 |
|
June 2013 |
December 2015 |
July 2016 |
November 4, 2013 |
August 27, 2015 |
|
- Celiac Disease Center, Fondazione IRCCS Cà Granda
Milano, Italy
|
|
| 58 |
NCT01317914 |
Completed |
Prospective Study of Undiagnosed Celiac Disease |
|
- Other: Dietary instruction
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Understanding the impact of undiagnosed celiac disease and the potential benefits of diagnosis
|
31 |
All |
60 Years and older (Adult, Older Adult) |
NCT01317914 |
10-000178 |
|
July 2010 |
April 2012 |
April 2012 |
March 17, 2011 |
October 2, 2017 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
|
| 59 |
NCT00671138 |
Completed |
Inoculating Celiac Disease Patients With the Human Hookworm Necator Americanus: Evaluating Immunity and Gluten-sensitivity |
|
- Biological: Necator americanus
- Other: Sham inoculation
|
Interventional
|
Phase 2 |
- Princess Alexandra Hospital, Brisbane, Australia
- The Broad Foundation
- Townsville Hospital
- (and 3 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Duodenal histology (Marsh classification) and rectal histology
- Peripheral blood mononuclear cells and mucosal lymphocytes will be grown ex vivo and challenged with gluten antigen immunodominant peptide. Cell proliferation and cytokine profiles will also be measured.
|
20 |
All |
18 Years and older (Adult, Older Adult) |
NCT00671138 |
2007/115
IBD-0214R |
|
October 2007 |
December 2008 |
September 2009 |
May 5, 2008 |
February 2, 2016 |
|
- Queensland Institute of Medical Research
Brisbane, Queensland, Australia - Princess Alexandra Hospital
Brisbane, Queensland, Australia - Logan Hospital
Logan, Queensland, Australia
|
|
| 60 |
NCT02690532 |
Completed |
Gut Permeability Assessment in Celiac and Gluten Sensitive Children |
|
|
Observational
|
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
|
40 |
All |
2 Years to 17 Years (Child) |
NCT02690532 |
15-006018 |
|
March 2016 |
July 1, 2018 |
August 1, 2018 |
February 24, 2016 |
August 15, 2018 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
|
| 61 |
NCT00810654 |
Completed |
Effect of Aspergillus Niger Prolyl Endoprotease (AN-PEP) Enzyme on the Effects of Gluten Ingestion in Patients With Coeliac Disease |
|
- Dietary Supplement: Aspergillus niger prolyl endoprotease
- Dietary Supplement: Placebo
|
Interventional
|
Phase 1
Phase 2 |
- VU University Medical Center
- DSM Food Specialties
- Leiden University Medical Center
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Histopathological changes according to the Modified Marsh criteria
- The presence of coeliac disease specific antibodies (EMA, tTGA, gliadin)
- Presence and activity of gluten reactive Tcells isolated from biopsies and serum
- (and 2 more...)
|
14 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00810654 |
RD.0601.54
NTR1281 |
|
May 2008 |
May 2009 |
December 2009 |
December 18, 2008 |
January 19, 2011 |
|
- VU University Medical Center
Amsterdam, Netherlands
|
|
| 62 |
NCT01396213 |
Completed |
A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease |
|
- Drug: Larazotide Acetate
- Drug: placebo
|
Interventional
|
Phase 2 |
- Innovate Biopharmaceuticals
- Teva Pharmaceuticals USA
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Assess the efficacy of larazotide acetate versus placebo for the treatment of celiac disease in adults as an adjunct to a gluten-free diet
- Assess the safety and tolerability of larazotide acetate in subjects with active celiac disease
- Validate a CeD PRO diary instrument in subjects with celiac disease
- Compare various efficacy endpoints during 12 weeks of double-blind treatment
|
342 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01396213 |
Clin1001-012 |
|
November 7, 2011 |
August 20, 2013 |
August 20, 2013 |
July 18, 2011 |
September 20, 2017 |
|
- Birmingham, Alabama, United States
- Mesa, Arizona, United States
- Tucson, Arizona, United States
- (and 59 more...)
|
|
| 63 |
NCT01137955 |
Completed |
Rifaximin for the Treatment of Persistent Symptoms in Patients With Celiac Disease |
|
- Drug: Rifaximin
- Drug: Placebo
|
Interventional
|
Not Applicable |
- Columbia University
- Valeant Pharmaceuticals International, Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- To evaluate Gastrointestinal Symptom Rating Scale (GSRS) score improvement after administration of study drug, compared to baseline (week 0)
- To evaluate Lactulose hydrogen breath test improvement after administration of study drug, compared to baseline (week 0)
|
41 |
All |
18 Years and older (Adult, Older Adult) |
NCT01137955 |
AAAB6531(Y3M00)
IRB-AAAB6531(Y3M00) |
|
October 2006 |
April 2008 |
April 2008 |
June 7, 2010 |
January 21, 2011 |
|
- Celiac Disease Center at Columbia University
New York, New York, United States
|
|
| 64 |
NCT02711696 |
Completed |
Randomized Clincal Trial on the Effect of a Restricted Gluten Contamination Elimination Diet Among Celiacs [GluCED] |
|
- Behavioral: GCED, Gluten Contamination Elimination Diet
|
Interventional
|
Not Applicable |
- Università degli Studi di Brescia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Histologic classification
- Celiac disease serology
- TCR+ T cells count
- Eosinophils count
|
30 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02711696 |
CD_GE_2013 |
GluCED |
March 2014 |
June 2015 |
January 2016 |
March 17, 2016 |
October 27, 2016 |
|
|
|
| 65 |
NCT00620451 |
Completed |
Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease |
|
- Drug: larazotide acetate
- Drug: placebo
|
Interventional
|
Phase 2 |
- Innovate Biopharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Assess the efficacy of larazotide acetate in inducing remission in subjects with active celiac disease
- Assess the safety and tolerability of larazotide acetate
- To prospectively validate the components of a composite weighted index of Celiac Disease activity (Celiac Disease Activity Rating Score, CeDARS), individually and as a whole.
- (and 2 more...)
|
105 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT00620451 |
AT1001-011 |
|
February 2008 |
July 2009 |
December 2009 |
February 21, 2008 |
September 20, 2017 |
|
- Study Site
Orange, California, United States - Study Site
San Francisco, California, United States - Study Site
Torrington, Connecticut, United States - (and 30 more...)
|
|
| 66 |
NCT00628823 |
Completed |
Treatment of Mild Enteropathy Celiac Disease |
|
- Dietary Supplement: Gluten-free diet
|
Interventional
|
Not Applicable |
- Tampere University Hospital
- Academy of Finland
- University of Tampere
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Small-Bowel mucosal morphology
- Endomysial antibodies, tissue transglutaminase antibodies, Small-Bowel mucosal inflammation, clinical symptoms, laboratory parameters, bone mineral density.
|
73 |
All |
16 Years and older (Child, Adult, Older Adult) |
NCT00628823 |
SA-115376 |
TMCD |
March 2003 |
June 2008 |
December 2008 |
March 5, 2008 |
May 17, 2016 |
|
- University of Tampere
Tampere, Finland
|
|
| 67 |
NCT00639444 |
Completed |
Risk of Celiac Disease and Age at Gluten Introduction |
|
- Dietary Supplement: gluten-free, normocaloric diet from 6 to 12 months
|
Interventional
|
Not Applicable |
- Università Politecnica delle Marche
- Associazione Italiana Celiachia (AIC)
- Menarini Group
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- prevalence of active CD
- prevalence of CD-related autoantibodies (IgA anti-transglutaminase)
|
703 |
All |
up to 6 Months (Child) |
NCT00639444 |
UPM-CE 204332 |
CELIPREV |
September 2004 |
December 2007 |
November 2013 |
March 20, 2008 |
December 10, 2013 |
|
- Department of Pediatrics, via Corridoni 11
Ancona, Italy
|
|
| 68 |
NCT00889473 |
Completed |
Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease |
|
- Drug: Larazotide acetate
- Drug: Placebo
- Dietary Supplement: Gluten 900 mg
|
Interventional
|
Phase 2 |
- Innovate Biopharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Response to gluten
- Anti-transglutaminase
|
42 |
All |
18 Years to 72 Years (Adult, Older Adult) |
NCT00889473 |
CLIN1001-006 Part B |
|
April 2009 |
November 2009 |
April 2010 |
April 29, 2009 |
September 20, 2017 |
|
- Study Site
Orange, California, United States - Study Site
Topeka, Kansas, United States - Study Site
Lexington, Kentucky, United States - (and 12 more...)
|
|
| 69 |
NCT00739128 |
Terminated |
Response to Hepatitis B Vaccine in Celiac Disease Patients |
|
- Biological: hepatitis B vaccine (EngerixB)
|
Interventional
|
Not Applicable |
- Shaare Zedek Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 1. The primary endpoint of the study will be comparison of the geometric mean titers of anti-HBs between the intradermal and the intramuscular groups.
- 1. Rate of responders four weeks after the completion of the series 2. Rate and characteristics of adverse drug reactions 3. Numerical increase in the antibodies titer before and after vaccination 4. Rate of responders in the cross over phase
|
210 |
All |
1 Year and older (Child, Adult, Older Adult) |
NCT00739128 |
15363.ct.il |
|
February 2009 |
March 2011 |
March 2011 |
August 21, 2008 |
April 15, 2011 |
|
|
|
| 70 |
NCT03244254 |
Not yet recruiting |
Intestinal Fatty Acid-binding Protein (I-FABP) Levels in Pediatric Celiac Patients |
- Celiac Disease in Children
|
|
Observational
|
|
- Schneider Children's Medical Center, Israel
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- I-FABP levels at diagnosis
- I-FABP levels during remission
|
70 |
All |
up to 17 Years (Child) |
NCT03244254 |
SchneiderCMCIsraelIFABP |
|
November 2017 |
August 2019 |
August 2020 |
August 9, 2017 |
October 4, 2017 |
|
- Schneider Children's Medical Center of Israel
Petaẖ Tiqwa, Israel
|
|
| 71 |
NCT01159457 |
Unknown † |
Comparison of Engerix B Vaccine Versus Sci-B-Vac Vaccine in Celiac Patients |
|
- Biological: Hepatitis B vaccination (Sci-B-Vac)
- Biological: Hepatitis B vaccination (EngerixB)
|
Interventional
|
Not Applicable |
- Shaare Zedek Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Comparison of the geometric mean titers of anti-HBs between the Engerix B group and the Sci-B-Vac group
- Rate of responders four weeks after the completion of the series
- Rate and characteristics of adverse drug reactions
- (and 4 more...)
|
210 |
All |
1 Year to 20 Years (Child, Adult) |
NCT01159457 |
15364.ct.il |
|
April 2011 |
June 2012 |
January 2013 |
July 9, 2010 |
April 15, 2011 |
|
|
|
| 72 |
NCT00540657 |
Completed |
A Phase II Study of CCX282-B in Patients With Celiac Disease |
|
- Drug: CCX282-B
- Drug: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Evaluation of the effect of CCX282-B compared to placebo on the villous height/crypt depth ratio of small intestinal biopsy specimens taken from subjects with celiac disease, before and after gluten exposure.
- Evaluation of CCX282-B compared to placebo on small intestinal mucosal inflammation before and after gluten exposure
- Evaluation of CCX282-B compared to placebo on gluten-induced celiac-type serology before and after gluten exposure
- Evaluation of CCX282-B compared to placebo on symptom scores before and after gluten exposure
|
90 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT00540657 |
CL009_282 |
|
October 2007 |
June 2008 |
July 2008 |
October 8, 2007 |
July 22, 2008 |
|
- Finn-Medi Research Ltd, Outpatient Clinic
Tampere, Finland
|
|
| 73 |
NCT02389062 |
Recruiting |
Noninvasive Markers of Gluten Ingestion in Celiac Disease Patients |
- Adult Form of Celiac Disease
|
- Other: Administration of gluten( food /wheat protein) capsules or placebo(cornstarch) capsules and tests for novel markers will be done at intervals.
|
Interventional
|
Not Applicable |
- Thomas Jefferson University
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Diagnostic
|
- 1) Change in the patient estimated gluten intake after administration of study pills using the Celiac Dietary Adherence Test (CDAT), to be assessed at the end of follow up week 12
- 2) Change in the Celiac disease symptoms, using the Celiac Symptom Index (CSI) after administration of study pills; to be assessed at the end of follow up week 12
- 3)Change in IgA antibody to tissue transglutaminase (IgA-TTG) levels after administration of study pills, to be assessed at the end of follow up week 12.
- (and 4 more...)
|
36 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT02389062 |
14D.389 |
|
February 2015 |
February 2017 |
February 2019 |
March 17, 2015 |
March 17, 2015 |
|
- Thomas Jefferson University
Philadelphia, Pennsylvania, United States
|
|
| 74 |
NCT00492960 |
Completed |
Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease |
|
- Drug: larazotide acetate
- Drug: placebo
- Dietary Supplement: 900 mg gluten
|
Interventional
|
Phase 2 |
- Innovate Biopharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Efficacy of multiple doses larazotide acetate in preventing intestinal permeability changes induced by a 6- week gluten challenge.
- Safety of a 6-week exposure to oral doses of larazotide acetate in celiac disease patients exposed to 900 mg gluten TID with meals
- To prospectively validate a composite, weighted index of celiac disease activity
|
171 |
All |
18 Years to 72 Years (Adult, Older Adult) |
NCT00492960 |
CLIN1001-006 |
|
August 2007 |
October 2008 |
March 2009 |
June 27, 2007 |
September 20, 2017 |
|
- Study Site
Scottsdale, Arizona, United States - Study Site
Colorado Springs, Colorado, United States - Study Site
Chicago, Illinois, United States - (and 20 more...)
|
|
| 75 |
NCT00386165 |
Completed |
Safety Study of Larazotide Acetate to Treat Celiac Disease. |
|
|
Interventional
|
Phase 1 |
- Innovate Biopharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Demonstrate the safety and tolerance of single doses of larazotide acetate in patients with controlled celiac disease on a gluten-free diet.
- Determine whether quantifiable concentrations of larazotide acetate are present in plasma following single oral doses and to characterize the pharmacokinetic behavior of larazotide acetate in celiac disease subjects that are gluten-free and in remission
- Evaluate the effects of single doses of larazotide acetate on intestinal permeability ratios and zonulin levels
- (and 2 more...)
|
21 |
All |
18 Years to 59 Years (Adult) |
NCT00386165 |
CLIN1001-002 |
|
November 29, 2005 |
January 26, 2006 |
January 26, 2006 |
October 11, 2006 |
September 11, 2017 |
|
- Parexel
Baltimore, Maryland, United States
|
|
| 76 |
NCT00362856 |
Completed |
Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects |
|
- Drug: larazotide acetate
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Innovate Biopharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- To demonstrate the safety and tolerability of multiple, oral doses of larazotide acetate in celiac disease subjects that maintain a gluten-free diet.
- To evaluate the efficacy of multiple dose levels of larazotide acetate in preventing intestinal permeability changes induced by gluten challenge
- Changes in daily and weekly reported health outcomes
- (and 7 more...)
|
80 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00362856 |
CLIN1001-004 |
|
September 13, 2006 |
March 6, 2007 |
March 6, 2007 |
August 10, 2006 |
September 12, 2017 |
|
- Research Site
Scottsdale, Arizona, United States - San Diego, California, United States
- Research Site
Boston, Massachusetts, United States - (and 6 more...)
|
|
| 77 |
NCT00879749 |
Completed |
Safety Study of Nexvax2 in Subjects With Coeliac Disease |
- Coeliac Disease
- Celiac Disease
|
- Biological: 9 micrograms Nexvax2
- Biological: 30 micrograms Nexvax2
- Biological: 90 micrograms Nexvax2
- (and 3 more...)
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
34 |
All |
18 Years to 60 Years (Adult) |
NCT00879749 |
Nexvax2-001 |
|
April 2009 |
March 2010 |
June 2010 |
April 10, 2009 |
April 7, 2011 |
|
- Q-Pharm Pty Ltd
Herston, Queensland, Australia - Nucleus Network - Centre for Clinical Studies
Melbourne, Victoria, Australia
|
|
| 78 |
NCT00175760 |
Completed |
Can a Very High Result From a Screening Test for Celiac Disease be Used to Diagnose Celiac Disease? |
|
- Procedure: Diagnosis of Celiac Disease
|
Observational
|
|
- University of British Columbia
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
100 |
All |
2 Months to 18 Years (Child, Adult) |
NCT00175760 |
C04-0304 |
|
December 2004 |
October 2006 |
October 2006 |
September 15, 2005 |
April 12, 2011 |
|
- BC Children's Hospital
Vancouver, British Columbia, Canada
|
|
| 79 |
NCT03483805 |
Completed |
Effects of a Nutritional Solution to Improve Intestinal Permeability in Celiac Patients |
|
- Dietary Supplement: Protalsafe
- Dietary Supplement: Placebo
|
Interventional
|
Not Applicable |
- Société Guaranteed Gluten Free (GGF)
- Institut Polytechnique UniLaSalle
- Institut Pasteur de Lille
- Association Française des Intolérants au Gluten (AFDIAG)
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Lactulose/mannitol recovery in 5-hour urine sample
- serum zonulin
- microbiota profile
- (and 5 more...)
|
44 |
All |
18 Years to 60 Years (Adult) |
NCT03483805 |
2016-A00330-51 |
Protalsafe |
December 21, 2016 |
January 12, 2018 |
January 12, 2018 |
March 30, 2018 |
April 20, 2018 |
|
- Institut Pasteur de Lille
Lille, France
|
|
| 80 |
NCT02946827 |
Unknown † |
A Low FODMAPs Diet in Celiac Patients With Persistent Gastrointestinal Symptoms |
|
- Dietary Supplement: Balanced low FODMAPs /gluten free diet
- Dietary Supplement: Balanced gluten free diet
|
Interventional
|
Not Applicable |
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Improvement of VAS (psychometric response scale level continuous line between two end-points 0-10) values of globel well-being in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients in balanced gluten free diet.
- Improvement of VAS values of IBS symptoms in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.
- Improvement of quality of life assessed through SF-36 questionnaire (eight scale scores) in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.
- (and 2 more...)
|
68 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02946827 |
2016/464 |
|
January 2016 |
November 2016 |
January 2017 |
October 27, 2016 |
October 27, 2016 |
|
- University of Milan
Milan, Italy
|
|
| 81 |
NCT02451449 |
Active, not recruiting |
Celiac Disease and Infertility Among Men and Women in Denmark |
- Celiac Disease
- Infertility
|
|
Observational
|
|
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- Prevalence of celiac disease
- Gastrointestinal symptoms of undiagnosed celiac disease
- Soluble CD163 mg/L
|
900 |
All |
18 Years to 40 Years (Adult) |
NCT02451449 |
CØF 2015 |
CØF2015 |
January 2015 |
September 2017 |
November 2018 |
May 22, 2015 |
October 26, 2017 |
|
- Fertility Clinic, Horsens Hospital
Horsens, Central Denmark Region, Denmark - Fertility Clinic, Skive Hospital
Skive, Central Denmark Region, Denmark
|
|
| 82 |
NCT02126033 |
Unknown † |
Telomeres Parameters in Celiac Disease |
|
- Procedure: take blood samples
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Parallel Assignment
- Primary Purpose: Basic Science
|
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT02126033 |
1234 |
|
|
December 2015 |
|
April 29, 2014 |
April 29, 2014 |
|
|
|
| 83 |
NCT03137862 |
Completed |
"Gluten Friendly" Treatment in Celiac Disease |
- Food Intolerance
- Celiac Disease
|
- Other: Gluten free bread
- Dietary Supplement: Gluten friendly bread 3g/day
- Dietary Supplement: Gluten friendly bread 6g/day
|
Interventional
|
Not Applicable |
- Casa Sollievo della Sofferenza IRCCS
- University of Foggia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Other
|
- Measure of small bowel mucosal density and evaluation of the serologic markers of celiac disease
|
45 |
All |
Child, Adult, Older Adult |
NCT03137862 |
NCT64/CE |
GLUFR |
March 20, 2017 |
April 2, 2017 |
January 15, 2018 |
May 3, 2017 |
August 9, 2018 |
|
- Angelo Andriulli
San Giovanni Rotondo, FG, Italy
|
|
| 84 |
NCT01990885 |
Completed |
Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients. |
|
- Drug: BL-7010
- Drug: Placebo
|
Interventional
|
Phase 1
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Incidence of adverse events
- Significant change from baseline in vital signs and 12-lead ECG parameters
- Significant change from baseline in laboratory safety parameters
- Plasma levels of BL-7010
|
40 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01990885 |
BL-7010.01 |
|
December 2013 |
October 2014 |
October 2014 |
November 25, 2013 |
August 18, 2017 |
|
- FinnMedi Clinical Trial Center
Tampere, Finland - CRST Clinical Research Services
Turku, Finland
|
|
| 85 |
NCT02442219 |
Completed |
A Blood Based Diagnostic Test for Coeliac Disease |
- Coeliac Disease
- Non Coeliac Gluten Sensitivity
|
|
Observational
|
|
- Oslo University Hospital
- The Research Council of Norway
|
Other |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- Ability of the tetramer test in differentiating persons with coeliac disease from controls by the use of tetramer staining for gluten specific T-cells and flowcytometry
|
144 |
All |
18 Years and older (Adult, Older Adult) |
NCT02442219 |
2011/2472 |
|
February 2015 |
December 2016 |
February 2017 |
May 13, 2015 |
April 6, 2017 |
|
- Oslo University hospital
Oslo, Norway
|
|
| 86 |
NCT03221647 |
Completed |
INF-α Innate Immune Response to Gliadin |
|
- Other: Intestinal biopsies
|
Observational
|
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Cross-Sectional
|
- Measurement of Mxa and INF alpha proteins in CD biopsies compared to controls
|
53 |
All |
2 Years to 17 Years (Child) |
NCT03221647 |
Innate immunity CD |
|
January 10, 2013 |
July 1, 2017 |
July 1, 2017 |
July 18, 2017 |
July 18, 2017 |
|
- Riccardo Troncone
Naples, Italy
|
|
| 87 |
NCT00859391 |
Completed |
Effects of Gluten Digestion With ALV003 |
|
|
Observational
|
|
- Alvine Pharmaceuticals Inc.
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The clinical response by symptom measurement before and after oral challenge
- The immune response measured by ELISPOT testing and celiac disease serology
- Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo
|
20 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT00859391 |
ALV0801 |
0801 |
May 2008 |
June 2008 |
June 2008 |
March 11, 2009 |
June 11, 2009 |
|
- Nucleus Networks Limited
Melbourne, Victoria, Australia
|
|
| 88 |
NCT02929316 |
Terminated |
Vedolizumab Induction May Prevent Celiac Enteritis |
|
|
Interventional
|
Phase 2 |
- AGA Clinical Research Associates, LLC
- Takeda
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Normal histopathology following induction dosing with vedolizumab
- Normal histopathology following induction dosing with vedolizumab after 2 week gluten challange
|
1 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02929316 |
IISR-2016-101481 |
|
June 25, 2018 |
October 5, 2018 |
October 5, 2018 |
October 11, 2016 |
October 10, 2018 |
|
- AGA Clinical Research Associates, LLC
Egg Harbor Township, New Jersey, United States - Theresa Stevens
Egg Harbor Township, New Jersey, United States
|
|
| 89 |
NCT00931892 |
Completed |
Serum Markers in Gluten Challenge |
|
- Dietary Supplement: Gluten
|
Interventional
|
Not Applicable |
- Beth Israel Deaconess Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Histological evaluation of duodenal biopsy samples to evaluate crypt depth to villous height ratio
- Histological evaluation of duodenal biopsy samples to determine the number of intraepithelial lymphocytes per 100 enterocytes
- Measures of intestinal permeability (urinary lactulose to mannitol ratio) and malabsorption (plasma prealbumin)
- (and 3 more...)
|
22 |
All |
17 Years to 72 Years (Child, Adult, Older Adult) |
NCT00931892 |
2007P000280 |
|
April 2009 |
August 2011 |
August 2011 |
July 2, 2009 |
October 23, 2018 |
|
- Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
|
|
| 90 |
NCT00555737 |
Completed |
Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy (MA-23) |
|
- Device: Capsule Endoscopy
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The number of findings identified during the capsule endoscopy or upper GI endoscopy procedure, and which were considered by the investigator as related to the gluten sensitive enteropathy origin
- Longitudinal extent of villous changes in the small bowel will be evaluated.
|
102 |
All |
18 Years and older (Adult, Older Adult) |
NCT00555737 |
MA-23 |
|
November 2003 |
|
July 2007 |
November 9, 2007 |
March 26, 2009 |
|
- University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States - University of Tampere Medical School
Tampere, Finland - Ospedale Maggiore - Policlinico
Milano, Italy - (and 2 more...)
|
|
| 91 |
NCT02916654 |
Recruiting |
Sucrosomial Iron in Patients With Celiac Disease and IDA |
- Celiac Disease
- Iron Deficiency Anemia
|
- Dietary Supplement: sucrosomial iron
- Drug: Sulphate iron
|
Interventional
|
Not Applicable |
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
20 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02916654 |
33_2014 |
|
April 2015 |
August 2016 |
December 2017 |
September 27, 2016 |
March 27, 2017 |
|
- Fondazione IRCCS Ca' Granda
Milano, MI, Italy
|
|
| 92 |
NCT00819819 |
Terminated |
Infant Nutrition and Risk of Celiac Disease |
- Celiac Disease
- Infant Nutrition
|
- Dietary Supplement: Gluten
- Dietary Supplement: Gluten free diet
|
Interventional
|
Not Applicable |
- Massachusetts General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Care Provider, Investigator)
- Primary Purpose: Prevention
|
- To evaluate the primary prevention of early onset celiac disease and related autoimmunity phenomena by comparing the frequency of disease development according to two different patterns of gluten introduction in at risk infants
|
80 |
All |
up to 6 Months (Child) |
NCT00819819 |
2013P000287 |
|
April 2008 |
July 2013 |
July 2013 |
January 9, 2009 |
March 22, 2017 |
|
- Massachusetts General Hospital East
Charlestown, Massachusetts, United States
|
|
| 93 |
NCT02472704 |
Completed |
Lymphocytic Enteritis and Suspected Coeliac Disease: Gluten vs Placebo |
- Celiac Disease
- Non-celiac Gluten Sensitivity
|
- Dietary Supplement: Gluten challenge
- Dietary Supplement: Placebo challenge
|
Interventional
|
Not Applicable |
- Hospital Mutua de Terrassa
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Clinical relapse
- Changes in health related quality of life
- Histological evolution (Changes in intraepithelial lymphocyte count)
- (and 2 more...)
|
18 |
All |
18 Years and older (Adult, Older Adult) |
NCT02472704 |
DSG-DC/01/01 |
|
September 2011 |
April 2014 |
May 2014 |
June 16, 2015 |
June 16, 2015 |
|
|
|
| 94 |
NCT00962182 |
Completed |
Study of Enzyme Supplements to Treat Celiac Disease |
- Celiac Disease
- Dermatitis Herpetiformis
|
- Drug: STAN1
- Drug: Placebo enzyme
- Drug: STAN1+gluten
|
Interventional
|
Phase 1
Phase 2 |
- Heim Pal Children's Hospital
- Stanford University
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Negative seroconversion or a drop of more than 50% in anti-transglutaminase antibody blood levels by ELISA
- Negative seroconversion or drop of at least two dilution steps in the EMA test
- Negative conversion for celiac antibodies in the blood by the rapid test
- (and 2 more...)
|
38 |
All |
12 Years to 65 Years (Child, Adult, Older Adult) |
NCT00962182 |
HP-03 |
|
August 2008 |
December 2014 |
December 2017 |
August 19, 2009 |
March 6, 2018 |
|
- Heim Pal Children's Hospital
Budapest, Hungary - University of Debrecen
Debrecen, Hungary
|
|
| 95 |
NCT02949765 |
Recruiting |
Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease |
- Celiac Disease
- Iron Deficiency (Without Anemia)
|
- Drug: Iron sulfate 105 mg
- Dietary Supplement: Iron-rich diet
|
Interventional
|
Not Applicable |
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Ferritin levels (ng/mL) increase > 95% compared to basal levels
- Hemoglobin levels (g/dL), compared to basal levels
- Iron levels (mcd/dl), compared to basal levels
- Transferrin saturation (%, ratio of serum iron and total iron-binding capacity), compared to basal levels
|
35 |
Female |
18 Years to 50 Years (Adult) |
NCT02949765 |
Atto 302/2016 |
|
December 2015 |
June 2017 |
September 2017 |
October 31, 2016 |
March 14, 2017 |
|
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy
|
|
| 96 |
NCT03011931 |
Recruiting |
Simvastatin Metabolism as a Test for CD Activity (IRB 15-007568] |
|
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Compare simvastatin metabolism with intestinal biopsies
- Villous height and crypt depth
- Dietary interview
- (and 3 more...)
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT03011931 |
15-007568 |
|
March 2016 |
December 2018 |
March 2019 |
January 6, 2017 |
March 21, 2018 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
|
| 97 |
NCT02072590 |
Recruiting |
Improved Diagnostics of Celiac Disease in Children |
- Celiac Disease
- Eosinophilic Esophagitis
|
|
Observational
|
|
- Tampere University Hospital
- Carol Davila University of Medicine and Pharmacy
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Transglutaminase 2 antibodies
- Serum endomysial antibodies
- Visual Analog Scale
- (and 3 more...)
|
2000 |
All |
up to 17 Years (Child) |
NCT02072590 |
R11187 |
|
August 2011 |
December 2022 |
December 2022 |
February 26, 2014 |
June 4, 2018 |
|
- Tampere Centre for Child Health Research, University of Tampere and Tampere University hospital
Tampere, Finland - University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania
Bucharest, Romania
|
|
| 98 |
NCT02325232 |
Unknown † |
Enteroscopy for Early Diagnosis of Tumors in Celiac Disease |
- Small Intestine Cancer
- Celiac Disease
|
- Device: Capsule endoscopy, double balloon enteroscopy sequential use
|
Interventional
|
Not Applicable |
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Identification of celiac patients at higher risk of developing small bowel neoplasia and evaluation of the the usefulness of VCE and DBE
- The diagnostic yeld of DBE and VCE in this setting of patients
|
200 |
All |
18 Years and older (Adult, Older Adult) |
NCT02325232 |
167
GR-2011-02348234 |
|
February 2012 |
May 2017 |
November 2017 |
December 24, 2014 |
August 27, 2015 |
|
- Celiac Disease Center, Fondazione IRCCS Cà Granda
Milano, Italy
|
|
| 99 |
NCT00250146 |
Terminated |
Multicenter Study on the Toxicity of Gluten Traces in the Treatment of Celiac Disease |
|
- Behavioral: Gluten (behaviour)
|
Interventional
|
Not Applicable |
- Università Politecnica delle Marche
- Associazione Italiana Celiachia (AIC)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Diagnostic
|
- Villous Height/Crypt Depth ratio on small intestinal biopsy
- Intraepithelial lymphocyte coun on small intestinal biopsy
- changes in serum IgA class anti-trasnglutaminase antibodies
- (and 2 more...)
|
39 |
All |
18 Years and older (Adult, Older Adult) |
NCT00250146 |
IRB-2000-611 |
|
February 2001 |
|
March 2005 |
November 7, 2005 |
November 7, 2005 |
|
- University Department of Pediatrics
Ancona, Italy
|
|
| 100 |
NCT01566110 |
Completed |
Celiac Disease and Diabetes- Dietary Intervention and Evaluation Trial |
- Celiac Disease
- Diabetes Mellitus, Type 1
|
- Dietary Supplement: Gluten Free Diet
|
Interventional
|
Not Applicable |
- The Hospital for Sick Children
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Metabolic Control
- Hypoglycemic Episodes
- Continuous Glucose Monitoring
|
50 |
All |
8 Years to 45 Years (Child, Adult) |
NCT01566110 |
1000030346 |
CD-DIET |
March 2012 |
March 2018 |
March 2018 |
March 29, 2012 |
September 5, 2018 |
|
- McMaster University
Hamilton, Ontario, Canada - Kingston General Hospital
Kingston, Ontario, Canada - London Health Sciences
London, Ontario, Canada - (and 4 more...)
|
|
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