NCT05680012 Tissue Destruction and Healing in Celiac Disease
| NCT ID | NCT05680012 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Chicago |
| Condition | Celiac Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2023-07-14 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2023-07-14 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Bana Jabri, MD
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT05680012 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Celiac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05680012 currently recruiting?
Yes, NCT05680012 is actively recruiting participants. Contact the research team at skupfer@bsd.uchicago.edu for enrollment information.
Where is the NCT05680012 trial being conducted?
This trial is being conducted at Pasadena, United States, Chicago, United States, Rochester, United States.
Who is sponsoring the NCT05680012 clinical trial?
NCT05680012 is sponsored by University of Chicago. The principal investigator is Bana Jabri, MD at University of Chicago. The trial plans to enroll 220 participants.