RECRUITING

Tissue Destruction and Healing in Celiac Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Tissue Destruction and Healing in Celiac Disease

Quick Facts

Study Start:2023-07-14
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05680012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18 to 75 years old
  2. 2. Diagnosis of Celiac disease for at least 12 months by intestinal biopsy
  3. 3. Follow a strict gluten-free diet for at least the 12 consecutive months
  4. 1. Age 18 to 75 years old
  5. 2. Showing typical celiac disease symptoms
  6. 3. Not on a gluten-free diet
  7. 1. Age 18 to 75 years old
  8. 2. Females who are not pregnant
  1. 1. Diagnosis of any severe complication of celiac disease
  2. 2. Diagnosis of other chronic, active GI disease
  3. 3. Selective IgA deficiency
  4. 4. Severe reaction to gluten exposure
  5. 5. Any clinically significant diseases
  6. 6. History of significant substance or alcohol abuse
  7. 7. Pregnant or lactating
  8. 8. Diagnosis of blood clotting disorders
  9. 1. History of chronic inflammatory gastrointestinal disease
  10. 2. Gastrointestinal illness within the 4-week period prior to screening
  11. 3. History of lymphoproliferative disease
  12. 4. Uncontrolled blood clotting disorders
  13. 5. Any clinically significant diseases
  14. 6. History of significant substance or alcohol abuse
  15. 1. Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs
  16. 2. Known intestinal inflammation
  17. 3. Prior gastrointestinal surgery
  18. 4. Taking of antiplatelet agents or anticoagulants
  19. 5. Family history of celiac disease

Contacts and Locations

Study Contact

Sonia Kupfer, MD
CONTACT
(773) 834-1438
skupfer@bsd.uchicago.edu
Kristi Kearney, RN
CONTACT
773-834-7414
kkearney@bsd.uchicago.edu

Principal Investigator

Bana Jabri, MD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

California Institute of Technology
Pasadena, California, 91125
United States
The University of Chicago
Chicago, Illinois, 60637
United States
Mayo Clinic
Rochester, Minnesota, 55902
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Bana Jabri, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-14
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-07-14
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • gluten-free diet
  • HLA-DQ2
  • HLA-DQ8
  • microbiome
  • metagenomics
  • intestinal epithelial cells

Additional Relevant MeSH Terms

  • Celiac Disease