Tissue Destruction and Healing in Celiac Disease

Launched by UNIVERSITY OF CHICAGO · Dec 23, 2022

Keywords

ClinConnect Summary

This clinical trial, titled "Tissue Destruction and Healing in Celiac Disease," aims to understand more about how celiac disease affects the body and its symptoms. Researchers want to learn how different factors—like the cells in the intestines, the bacteria that live there, the immune system, genetics, and gluten—interact and influence the disease’s severity and the healing process. By gathering this information, they hope to improve care and resources for patients with celiac disease.

To be eligible for this study, participants should be between 18 and 75 years old and meet specific criteria. For the gluten challenge group, individuals must have been diagnosed with celiac disease for at least a year and have been following a strict gluten-free diet for the past 12 months. The gluten de-challenge group should be experiencing typical symptoms of celiac disease but not following a gluten-free diet. Control participants should be healthy females who are not pregnant. Those interested in participating can expect to undergo evaluations that help researchers gather important data, and it’s essential to know that there are certain health conditions and medications that could exclude someone from participating.

Gender

ALL

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