Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT05680012

Tissue Destruction and Healing in Celiac Disease

Led by University of Chicago · Updated on 2026-05-11

220

Participants Needed

3

Research Sites

206 weeks

Total Duration

On this page

Sponsors

U

University of Chicago

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Tissue Destruction and Healing in Celiac Disease

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years old
  • Diagnosis of celiac disease for at least 12 months by intestinal biopsy (for gluten challenge group)
  • Following a strict gluten-free diet for at least 12 consecutive months (for gluten challenge group)
  • Showing typical celiac disease symptoms (for gluten de-challenge group)
  • Not on a gluten-free diet (for gluten de-challenge group)
  • Females who are not pregnant (for control group)
  • Age 18 to 75 years old (for gluten de-challenge and control groups)
Not Eligible

You will not qualify if you...

  • Diagnosis of any severe complication of celiac disease (gluten challenge group)
  • Diagnosis of other chronic, active gastrointestinal disease (gluten challenge group)
  • Selective IgA deficiency (gluten challenge group)
  • Severe reaction to gluten exposure (gluten challenge group)
  • Any clinically significant diseases (gluten challenge and gluten de-challenge groups)
  • History of significant substance or alcohol abuse (gluten challenge and gluten de-challenge groups)
  • Pregnant or lactating (gluten challenge group)
  • Diagnosis of blood clotting disorders (gluten challenge group)
  • History of chronic inflammatory gastrointestinal disease (gluten de-challenge group)
  • Gastrointestinal illness within 4 weeks prior to screening (gluten de-challenge group)
  • History of lymphoproliferative disease (gluten de-challenge group)
  • Uncontrolled blood clotting disorders (gluten de-challenge group)
  • Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs (control group)
  • Known intestinal inflammation (control group)
  • Prior gastrointestinal surgery (control group)
  • Taking antiplatelet agents or anticoagulants (control group)
  • Family history of celiac disease (control group)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

California Institute of Technology

Pasadena, California, United States, 91125

Not Yet Recruiting

2

The University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

3

Mayo Clinic

Rochester, Minnesota, United States, 55902

Actively Recruiting

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Research Team

S

Sonia Kupfer, MD

CONTACT

K

Kristi Kearney, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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