Understanding tissue damage and healing in celiac disease

Tissue Destruction and Healing in Celiac Disease

This study is trying to understand how gluten and other factors affect tissue damage and healing in people with celiac disease, comparing those on a gluten-free diet to those who still eat gluten.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Chicago (Academic / other)
• Locations: 3 sites (Pasadena, California and 2 other locations)
• Trial ID: NCT05680012 on ClinicalTrials.gov

What this trial studies

This clinical study aims to investigate the biological mechanisms behind celiac disease, focusing on how factors like genetics, microbiota, and gluten affect tissue damage and healing. Participants will be divided into groups based on their gluten consumption: those on a gluten-free diet and those experiencing symptoms without dietary restrictions. The study will collect data on clinical symptoms and tissue health to improve patient care and understanding of the disease. By examining these interactions, researchers hope to fill gaps in knowledge regarding the variability in disease presentation and recovery among individuals.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with a confirmed diagnosis of celiac disease who have been on a gluten-free diet for at least 12 months or those showing typical symptoms without dietary restrictions.

Not a fit: Patients with severe complications of celiac disease or other chronic gastrointestinal diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and treatment strategies for patients with celiac disease.

How similar studies have performed: Other studies have explored aspects of celiac disease, but this specific approach to understanding tissue destruction and healing is relatively novel.

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

Where this trial is running

Pasadena, California and 2 other locations

• California Institute of Technology — Pasadena, California, United States (Not_yet_recruiting)
• The University of Chicago — Chicago, Illinois, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Bana Jabri, MD — University of Chicago
• Study coordinator: Sonia Kupfer, MD

Conditions Celiac Disease; gluten-free diet; HLA-DQ2; HLA-DQ8; microbiome; metagenomics; intestinal epithelial cells