Recruiting

Celiac Disease

Sponsor:

University of Chicago

Code:

NCT05680012

Conditions

Celiac Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Gluten containing snack bar

Study Details

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.

Conditions

Celiac Disease

Study ID

NCT05680012

Start date

Jul 14, 2023

Status verified date

Jul, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

220 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Gluten containing snack bar

Ingest snack bars containing 3 grams of gluten every day for 6 weeks.

Primary outcome measure

  • Gluten challenge group: quantitative analysis of intestinal villus to crypt ratios [ Time Frame: baseline - 6 weeks ]
  • Gluten de-challenge group: quantitative analysis of intestinal villus to crypt ratios [ Time Frame: baseline -12 months ]

Central Contacts and Locations

Locations

The University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

More Information

Sponsor

University of Chicago

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • gluten-free diet
  • HLA-DQ2
  • HLA-DQ8
  • microbiome
  • metagenomics
  • intestinal epithelial cells

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-07-28.