Gluten Challenge for Celiac Disease
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but if you are in the control group, you cannot take antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs.
Is the gluten challenge safe for humans?
How does the gluten-containing snack bar treatment for celiac disease differ from other treatments?
What is the purpose of this trial?
The purpose of this clinical study is to learn more about celiac disease pathogenesis and clinical symptoms. In particular, this study will examine the interactions between biological factors such as, intestinal epithelial cells, microbiota, immune system, genetics, and gluten and their effect on celiac disease clinical symptoms, and severity of tissue destruction and its ability to heal in individuals with celiac disease. Information collected in the study will help researchers to generate better resources to advance celiac disease patient care.
Research Team
Bana Jabri, MD
Principal Investigator
University of Chicago
Eligibility Criteria
Adults aged 18-70 with celiac disease can join this trial. Participants must have been diagnosed by biopsy at least a year ago and followed a strict gluten-free diet for the past year. Pregnant women, those with chronic GI diseases, uncontrolled blood disorders, or severe reactions to gluten are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Gluten Challenge
Participants with diagnosed celiac disease undergo a gluten challenge to assess intestinal responses
Gluten De-challenge
Participants suspected of celiac disease are monitored while maintaining a gluten-free diet
Follow-up
Participants are monitored for safety and effectiveness after the gluten challenge and de-challenge phases
Treatment Details
Interventions
- Gluten containing snack bar
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
Mayo Clinic
Collaborator
California Institute of Technology
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator