NCT05680012 · University of Chicago
Tissue Destruction and Healing in Celiac Disease
What this study is about
The purpose of this clinical study is to learn more about celiac disease pathogenesis and clinical symptoms.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Gluten challenge group:
- Age 18 to 75 years old
- Diagnosis of Celiac disease for at least 12 months by intestinal biopsy
- Follow a strict gluten-free diet for at least the 12 consecutive months Gluten de-challenge group:
- Age 18 to 75 years old
- Showing typical celiac disease symptoms
- Not on a gluten-free diet Control group:
- Age 18 to 75 years old
- Females who are not pregnant
Exclusion criteria
- Gluten challenge group:
- Diagnosis of any severe complication of celiac disease
- Diagnosis of other chronic, active GI disease
- Selective IgA deficiency
- Severe reaction to gluten exposure
- Any clinically significant diseases
- History of significant substance or alcohol abuse
- Pregnant or lactating
- Diagnosis of blood clotting disorders Gluten de-challenge group:
- History of chronic inflammatory gastrointestinal disease
- Gastrointestinal illness within the 4-week period prior to screening
- History of lymphoproliferative disease
- Uncontrolled blood clotting disorders
- Any clinically significant diseases
- History of significant substance or alcohol abuse Control group:
- Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs
- Known intestinal inflammation
- Prior gastrointestinal surgery
- Taking of antiplatelet agents or anticoagulants
- Family history of celiac disease
Where
- Pasadena, California
- Chicago, Illinois
- Rochester, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations