Actively Recruiting
Tissue Destruction and Healing in Celiac Disease
Led by University of Chicago · Updated on 2026-05-11
220
Participants Needed
3
Research Sites
206 weeks
Total Duration
On this page
Sponsors
U
University of Chicago
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tissue Destruction and Healing in Celiac Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old
- Diagnosis of celiac disease for at least 12 months by intestinal biopsy (for gluten challenge group)
- Following a strict gluten-free diet for at least 12 consecutive months (for gluten challenge group)
- Showing typical celiac disease symptoms (for gluten de-challenge group)
- Not on a gluten-free diet (for gluten de-challenge group)
- Females who are not pregnant (for control group)
- Age 18 to 75 years old (for gluten de-challenge and control groups)
You will not qualify if you...
- Diagnosis of any severe complication of celiac disease (gluten challenge group)
- Diagnosis of other chronic, active gastrointestinal disease (gluten challenge group)
- Selective IgA deficiency (gluten challenge group)
- Severe reaction to gluten exposure (gluten challenge group)
- Any clinically significant diseases (gluten challenge and gluten de-challenge groups)
- History of significant substance or alcohol abuse (gluten challenge and gluten de-challenge groups)
- Pregnant or lactating (gluten challenge group)
- Diagnosis of blood clotting disorders (gluten challenge group)
- History of chronic inflammatory gastrointestinal disease (gluten de-challenge group)
- Gastrointestinal illness within 4 weeks prior to screening (gluten de-challenge group)
- History of lymphoproliferative disease (gluten de-challenge group)
- Uncontrolled blood clotting disorders (gluten de-challenge group)
- Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs (control group)
- Known intestinal inflammation (control group)
- Prior gastrointestinal surgery (control group)
- Taking antiplatelet agents or anticoagulants (control group)
- Family history of celiac disease (control group)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
California Institute of Technology
Pasadena, California, United States, 91125
Not Yet Recruiting
2
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
3
Mayo Clinic
Rochester, Minnesota, United States, 55902
Actively Recruiting
Research Team
S
Sonia Kupfer, MD
CONTACT
K
Kristi Kearney, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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