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Tissue Destruction and Healing in Celiac Disease

University of Chicago · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Mayo Clinic · NCT05680012

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
220
US sites recruiting
2
Study start
July 14, 2023
Record last updated
July 28, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Gluten containing snack bar

Conditions: Celiac Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

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

Exclusion Criteria

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
  • History of significant substance or alcohol abuse

Control group

  • Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs
  • Known intestinal inflammation
  • Prior gastrointestinal surgery
  • Taking of antiplatelet agents or anticoagulants
  • Family history of celiac disease

Recruiting US locations

  • The University of Chicago

    Chicago, IL 60637

    Site contact: Bana Jabri, MD · bjabri@bsd.uchicago.edu

  • Mayo Clinic

    Rochester, MN 55902

    Site contact: Joseph Murray, MD · Murray.Joseph@mayo.edu

Study contacts (from the official record)

  • Sonia Kupfer, MD · (773) 834-1438 · skupfer@bsd.uchicago.edu
  • Kristi Kearney, RN · 773-834-7414 · kkearney@bsd.uchicago.edu
Tissue Destruction and Healing in Celiac Disease (NCT05680012) | Bored Studies