Tissue Destruction and Healing in Celiac Disease
University of Chicago
220 participants
Jul 14, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- Gluten challenge group:
- Age 18 to 75 years old
- Diagnosis of Celiac disease for at least 12 months by intestinal biopsy
- Follow a strict gluten-free diet for at least the 12 consecutive months
- Gluten de-challenge group:
- Age 18 to 75 years old
- Showing typical celiac disease symptoms
- Not on a gluten-free diet
- Control group:
- Age 18 to 75 years old
- Females who are not pregnant
Exclusion Criteria22
- Gluten challenge group:
- Diagnosis of any severe complication of celiac disease
- Diagnosis of other chronic, active GI disease
- Selective IgA deficiency
- Severe reaction to gluten exposure
- Any clinically significant diseases
- History of significant substance or alcohol abuse
- Pregnant or lactating
- Diagnosis of blood clotting disorders
- Gluten de-challenge group:
- History of chronic inflammatory gastrointestinal disease
- Gastrointestinal illness within the 4-week period prior to screening
- History of lymphoproliferative disease
- Uncontrolled blood clotting disorders
- Any clinically significant diseases
- History of significant substance or alcohol abuse
- Control group:
- Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs
- Known intestinal inflammation
- Prior gastrointestinal surgery
- Taking of antiplatelet agents or anticoagulants
- Family history of celiac disease
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Interventions
Ingest snack bars containing 3 grams of gluten every day for 6 weeks.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05680012