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Tissue Destruction and Healing in Celiac Disease
Who can join
Ages 18 to 75 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: Gluten challenge group: 1. Age 18 to 75 years old 2. Diagnosis of Celiac disease for at least 12 months by intestinal biopsy 3. Follow a strict gluten-free diet for at least the 12 consecutive months Gluten de-challenge group: 1. Age 18 to 75 years old 2. Showing typical celiac disease symptoms 3. Not on a gluten-free diet Control group: 1. Age 18 to 75 years old 2. Females who are not pregnant Exclusion Criteria: Gluten challenge group: 1. Diagnosis of any severe complication of celiac disease 2. Diagnosis of other chronic, active GI disease 3. Selective IgA deficiency 4. Severe reaction to gluten exposure 5. Any clinically significant diseases 6. History of significant substance or alcohol abuse 7. Pregnant or lactating 8. Diagnosis of blood clotting disorders Gluten de-challenge group: 1. History of chronic inflammatory gastrointestinal disease 2. Gastrointestinal illness within the 4-week period prior to screening 3. History of lymphoproliferative disease 4. Uncontrolled blood clotting disorders 5. Any clinically significant diseases 6. History of significant substance or alcohol abuse Control group: 1. Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs 2. Known intestinal inflammation 3. Prior gastrointestinal surgery 4. Taking of antiplatelet agents or anticoagulants 5. Family history of celiac disease
About the study
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.
What is being tested
- Gluten containing snack bar (dietary supplement)
Sponsor: University of Chicago · Participants: 220 · Started: Jul 14, 2023
Contact the study team
- Sonia Kupfer, MD · Phone: (773) 834-1438
- Kristi Kearney, RN · Phone: 773-834-7414
Official record on ClinicalTrials.gov — NCT05680012
Locations in the U.S.
| California | California Institute of Technology, Pasadena (Not yet recruiting) |
| Illinois | The University of Chicago, Chicago |
| Minnesota | Mayo Clinic, Rochester |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.