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Multimodal Approach in IBD Patients (MAID)

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ClinicalTrials.gov Identifier: NCT01705522
Recruitment Status : Recruiting
First Posted : October 12, 2012
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina

Brief Summary:
The investigators intend to assess the role of several biomarkers in the prediction of relapse in IBD. Clinical, laboratory and endoscopic data will be gathered and a predictive score will be derived in order to assess the relapse risk at 1 year.

Condition or disease
Ulcerative Colitis Crohn's Disease Nonalcoholic Fatty Liver Disease (NAFLD) Vitamin D Deficiency

Detailed Description:

Patients with a confirmed diagnosis of IBD will be prospectively assessed on a yearly basis in order to assess relapse risk factors.

Disease activity will be assessed using the Mayo score for UC patients and CDAI for Crohn's disease and endoscopic activity will be assessed using the Mayo endoscopic subscore for UC patients and the Simple Endoscopic Score for Crohn's Disease for CD patients.

Serum and fecal biomarkers will be obtainted at each study visit (C-reactive protein, fecal calprotectin).

Data about current and past medication for IBD will also be gathered.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multimodal Approach in IBD Patients
Study Start Date : October 2012
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019


Group/Cohort
IBD patients
patients with ulcerative colitis or crohn's disease, in remission



Primary Outcome Measures :
  1. Clinical relapse [ Time Frame: 1 year ]
    clinical relapse as assessed by conventional scores for activity in IBD - Mayo or CDAI

  2. Prevalence of NAFLD [ Time Frame: 1 year ]
    to assess the prevalence of nonalcoholic liver disease in IBD patients

  3. prevalence of vitamin D deficiency [ Time Frame: 1 year ]
    to assess vitamin D deficiency and osteopenia among IBD patients


Biospecimen Retention:   Samples Without DNA
serum and fecal samples


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all patients with IBD over 18 years of age, currently in clinical remission
Criteria

Inclusion Criteria:

  • ulcerative colitis or Crohn's disease
  • age over 18
  • clinical remission
  • signed informed consent

Exclusion Criteria:

  • pregnant women
  • refusal to sign informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705522


Contacts
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Contact: Theodor A Voiosu, MD 0040726732764 theodor.voiosu@gmail.com

Locations
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Romania
Colentina Clinical Hospital Recruiting
Bucharest, Romania, 020125
Contact: Andreea Bengus, MD    0040744497626    andreeabengus@yahoo.com   
Principal Investigator: Theodor A Voiosu, MD         
Sponsors and Collaborators
Clinical Hospital Colentina
Investigators
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Principal Investigator: Theodor Voiosu, Md Clinical Hospital Colentina

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: dr. Theodor Alexandru Voiosu, Gastroenterology resident, Teaching Assistant, Clinical Hospital Colentina
ClinicalTrials.gov Identifier: NCT01705522     History of Changes
Other Study ID Numbers: COL-GASTRO-3
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Keywords provided by dr. Theodor Alexandru Voiosu, Clinical Hospital Colentina:
IBD
ulcerative colitis
Crohn's disease
NAFLD
biomarkers
vitamin D
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Liver Diseases
Colitis, Ulcerative
Fatty Liver
Non-alcoholic Fatty Liver Disease
Vitamin D Deficiency
Ulcer
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders