Tissue Destruction and Healing in Celiac Disease

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

⁃ 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

Locations
United States
California
California Institute of Technology
NOT_YET_RECRUITING
Pasadena
Illinois
The University of Chicago
RECRUITING
Chicago
Minnesota
Mayo Clinic
RECRUITING
Rochester
Contact Information
Primary
Sonia Kupfer, MD
skupfer@bsd.uchicago.edu
(773) 834-1438
Backup
Kristi Kearney, RN
kkearney@bsd.uchicago.edu
773-834-7414
Time Frame
Start Date: 2023-07-14
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 220
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), California Institute of Technology
Leads: University of Chicago

This content was sourced from clinicaltrials.gov