Tissue Destruction and Healing in Celiac Disease

July 24, 2026 updated by: University of Chicago
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gluten challenge group
Diagnosis of celiac disease by intestinal biopsy and serology for at least 12 months
Dietary supplement: Gluten containing snack bar
Ingest snack bars containing 3 grams of gluten every day for 6 weeks.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gluten challenge group: quantitative analysis of intestinal villus to crypt ratios
Time Frame: baseline - 6 weeks
villus to crypt ratios will be quantified on small bowel biopsy samples for the histologic quantification of intestinal responses to disease processes.
baseline - 6 weeks
Gluten de-challenge group: quantitative analysis of intestinal villus to crypt ratios
Time Frame: baseline -12 months
Villus to crypt ratios will be quantified on small bowel biopsy samples for the histologic quantification of intestinal responses to disease processes.
baseline -12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
California Institute of Technology

Investigators

  • Principal Investigator: Bana Jabri, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

December 23, 2022

First Posted (Actual)

January 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB22-1138
  • RC2DK133947 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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