NCT05680012

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Jul 2023Jun 2027

First Submitted

Initial submission to the registry

December 5, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

July 14, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

December 5, 2022

Last Update Submit

February 19, 2026

Conditions

Celiac Disease

Keywords

gluten-free dietHLA-DQ2HLA-DQ8microbiomemetagenomicsintestinal epithelial cells

Outcome Measures

Primary Outcomes (2)

  • Gluten challenge group: quantitative analysis of intestinal villus to crypt ratios

    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

    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

Study Arms (3)

Gluten challenge group

EXPERIMENTAL

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

Dietary Supplement: Gluten containing snack bar

Gluten de-challenge group

NO INTERVENTION

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

Control group

NO INTERVENTION

No history or symptoms of celiac disease

Interventions

Gluten containing snack barDIETARY_SUPPLEMENT

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

Gluten challenge group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gluten challenge group:
  • Age 18 to 75 years old
  • Diagnosis of Celiac disease for at least 12 months by intestinal biopsy
  • Follow a strict gluten-free diet for at least the 12 consecutive months
  • Gluten de-challenge group:
  • Age 18 to 75 years old
  • Showing typical celiac disease symptoms
  • Not on a gluten-free diet
  • Control group:
  • Age 18 to 75 years old
  • Females who are not pregnant

You may not qualify if:

  • Gluten challenge group:
  • Diagnosis of any severe complication of celiac disease
  • Diagnosis of other chronic, active GI disease
  • Selective IgA deficiency
  • Severe reaction to gluten exposure
  • Any clinically significant diseases
  • History of significant substance or alcohol abuse
  • Pregnant or lactating
  • Diagnosis of blood clotting disorders
  • Gluten de-challenge group:
  • History of chronic inflammatory gastrointestinal disease
  • Gastrointestinal illness within the 4-week period prior to screening
  • History of lymphoproliferative disease
  • Uncontrolled blood clotting disorders
  • Any clinically significant diseases
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

California Institute of Technology

Pasadena, California, 91125, United States

NOT YET RECRUITING

The University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55902, United States

RECRUITING

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bana Jabri, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonia Kupfer, MD

CONTACT

(773) 834-1438skupfer@bsd.uchicago.edu

Kristi Kearney, RN

CONTACT

773-834-7414kkearney@bsd.uchicago.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2022

First Posted

January 11, 2023

Study Start

July 14, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)