Tissue Destruction and Healing in Celiac Disease

Part of paid clinical trials in Pasadena, California.

Sponsor
University of Chicago
Study ID
NCT05680012
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Gluten containing snack bar — DIETARY_SUPPLEMENT
    Ingest snack bars containing 3 grams of gluten every day for 6 weeks.

Study Details

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.

Key Dates

Start date
Jul 14, 2023
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
California Institute of TechnologyPasadenaCalifornia91125
Rustem Ismagilov, PhD
[email protected]
626-395-8130
The University of ChicagoChicagoIllinois60637
Bana Jabri, MD
[email protected]
Sonia Kupfer, MD
[email protected]
Mayo ClinicRochesterMinnesota55902
Joseph Murray, MD
[email protected]
Chadrick Hinson
[email protected]
507-266-0237

Find similar trials in Pasadena, CA

By condition
Celiac disease
By specialty
GastroenterologyAutoimmune disease
By research site
California Institute of Technology· Pasadena, CAThe University of Chicago· Chicago, ILMayo Clinic· Rochester, MN

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