Tissue Destruction and Healing in Celiac Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

Gluten challenge group: 1. Age 18 to 70 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 70 years old. 2. Showing typical celiac disease symptoms. 3. Not on a gluten-free diet. Control group: 1. Age 18 to 70 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05680012
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Chicago
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bana Jabri, MD
Principal Investigator Affiliation	University of Chicago
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Celiac Disease

Additional Details

Celiac disease is an autoimmune enteropathy characterized by chronic inflammation of the small intestinal mucosa triggered by gluten uptake that occurs in genetically susceptible individuals carrying the specific class II human leucocyte antigens (HLA) DQ2 and DQ8 alleles. There is a spectrum in intestinal tissue damage associated with celiac disease. Some individuals develop inflammatory immunity in the absence of tissue damage, while others experience tissue damage ranging from partial to total villous atrophy. Persistent mucosal damage is associated with several severe complications, including lymphoproliferative malignancy and bone diseases. In addition, individuals with active celiac disease display a wide range of clinical symptoms, including metabolic defects that are not correlated to the degree of villous atrophy. Although much progress has been made in understanding celiac disease, major gaps remain in understanding biological mechanisms underlying inter-individual differences in clinical presentations and capacity to heal while maintaining a gluten-free diet.

Arms & Interventions

Arms

Experimental: Gluten challenge group

Diagnosis of celiac disease by intestinal biopsy and serology for at least 12 months

No Intervention: Gluten de-challenge group

Suspected celiac disease either showing typical symptoms or positive celiac disease serology

No Intervention: Control group

No history or symptoms of celiac disease

Interventions

Dietary Supplement: - Gluten containing snack bar

Ingest snack bars containing 3 grams of gluten every day for 7 weeks.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

California Institute of Technology, Pasadena, California

Status

Not yet recruiting

Address

California Institute of Technology

Pasadena, California, 91125

Site Contact

Rustem Ismagilov, PhD

rustem.admin@caltech.edu

626-395-8130

The University of Chicago, Chicago, Illinois

Status

Recruiting

Address

The University of Chicago

Chicago, Illinois, 60637

Site Contact

Bana Jabri, MD

bjabri@bsd.uchicago.edu

(773) 834-1438

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55902

Site Contact

Joseph Murray, MD

Murray.Joseph@mayo.edu

(773) 834-1438

Clinical Trial Finder