Tissue Destruction and Healing in Celiac Disease

Last updated: January 10, 2025
Sponsor: University of Chicago
Overall Status: Active - Recruiting

Phase

N/A

Condition

Celiac Disease

Treatment

Gluten containing snack bar

Clinical Study ID

NCT05680012
IRB22-1138
RC2DK133947
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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

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-steroidalanti-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

Total Participants: 220
Treatment Group(s): 1
Primary Treatment: Gluten containing snack bar
Phase:
Study Start date:
July 14, 2023
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • California Institute of Technology

    Pasadena, California 91125
    United States

    Site Not Available

  • The University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55902
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.