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Tissue Destruction and Healing in Celiac Disease

RecruitingHealthy volunteers welcome

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

Sponsor: University of Chicago · Participants: 220 · Started: Jul 14, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05680012

Locations in the U.S.

CaliforniaCalifornia Institute of Technology, Pasadena (Not yet recruiting)
IllinoisThe University of Chicago, Chicago
MinnesotaMayo Clinic, Rochester

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.