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Gluten Challenge in Celiac Disease

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ClinicalTrials.gov Identifier: NCT02464150
Recruitment Status : Recruiting
First Posted : June 8, 2015
Last Update Posted : July 14, 2020
Sponsor:
Collaborators:
Stiftelsen Helse og Rehabilitering
Helse Sor-Ost
Information provided by (Responsible Party):
Knut E. A. Lundin, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE March 30, 2015
First Posted Date  ICMJE June 8, 2015
Last Update Posted Date July 14, 2020
Actual Study Start Date  ICMJE April 1, 2017
Estimated Primary Completion Date August 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2017)
Transcriptome of gluten-specific T cells [ Time Frame: Day 6 ]
Transcriptional differences of glutenspecific vs. unspecific T cells
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2015)
  • Ratio of subjects with celiac disease showing diagnostic celiac lesion in small intestinal biopsy by microscopical examination after 2 weeks of gluten challenge [ Time Frame: Upto 25 months from start ]
    For the celiac disease sub study
  • Symptomatic responses as measured by Gastrointestinal Symptom Rating Scale - Irritable Bowel Disease after blinded challenge of non celiac gluten sensitive (ncgs) subjects with either gluten, FODMAP or placebo. [ Time Frame: Upto 25 months from start. ]
    For the non celiac gluten sensitivity sub study. There are two primary outcomes as there are two parallel studies
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gluten Challenge in Celiac Disease
Official Title  ICMJE Gluten Challenge in Celiac Disease
Brief Summary

Up till 30 participants with celiac disease on a glutenfree diet are asked to consume gluten containing cookies or bread for 3 days.

Questionnaires and sampling of blood is done before, during and after.

Detailed Description Before and 6 days after start of gluten challenge, blood samples will be collected and analysed by using HLA-tetramers to identify and purify CD4+ gluten-specific T cells by flow cytometry. T cells will undergo transcriptome analysis to get an insight in signalling of antigen-specific cells. Other cell populations like CD8+ T cells and γδ T cells will also be analyzed by flow cytometry.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Celiac Disease
Intervention  ICMJE Dietary Supplement: Gluten challenge
Challenge done in the form of a gluten containing cookie once daily, or up to four slices of regular bread daily.
Study Arms  ICMJE Experimental: Participants
Participants are subjected to gluten intervention in an unblinded fashion.
Intervention: Dietary Supplement: Gluten challenge
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 26, 2017)
10
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2015)
86
Estimated Study Completion Date  ICMJE August 2028
Estimated Primary Completion Date August 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Celiac disease confirmed by biopsy
  • Age 18 - 80 years
  • Gluten free diet last 6 months
  • Subject has received information and signed the informed consent form

Exclusion Criteria:

  • Pregnant or breast feeding
  • Probability of participant becoming pregnant (f.ex. by not using adequate sexual prevention by woman in fertile age)
  • Drugs influencing immune system used last 3 months
  • Current infectious disease of moderate or high severity
  • Other chronic active intestinal disease
  • Serious reaction on small amounts of gluten ingested
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stephanie Zühlke, MD 23074224 ext +47 stephanie.zuhlke@medisin.uio.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02464150
Other Study ID Numbers  ICMJE 2013/1237
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Knut E. A. Lundin, Oslo University Hospital
Original Responsible Party Knut E. A. Lundin, Oslo University Hospital, Associate professor, dr. med., M.D., Consultant physician
Current Study Sponsor  ICMJE Oslo University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Stiftelsen Helse og Rehabilitering
  • Helse Sor-Ost
Investigators  ICMJE
Principal Investigator: Knut EA Lundin, MD PhD Oslo University Hospital and University of Oslo
PRS Account Oslo University Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP