Gluten Technology and Education for Celiac Health

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The investigators propose to plan for a multi-center randomized controlled trial (M-RCT) to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in newly diagnosed adults. If successful, the proposed intervention will improve mucosal recovery, promote a shift in current practice of celiac disease management toward long-term monitoring, and represent a significant step toward reducing the severe physical and psychological consequences of celiac disease.

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

• Any gender; Age 18-75 years

• Celiac disease diagnosis by serology and duodenal biopsy (corresponding to •Marsh 3 histology), adequate sampling and interpretable villus height to crypt depth ratio upon review by our study pathologist

• Diagnosed with celiac disease within 4 months of initial study screening

• Willingness to use gluten-detection technology

• Not currently using a gluten detection technology that tests for gluten in urine or stool

• Seeing a clinician at one of the four recruitment sites

• Having already had an initial dietitian visit at one of the participating celiac disease centers

Locations
United States
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
New York
Columbia University Irving Medical Center
RECRUITING
New York
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Benjamin Lebwohl, MD, MS
BL114@cumc.columbia.edu
212-305-9338
Backup
Randi Wolf, PhD, MPH
212-678-3912
Time Frame
Start Date: 2024-10-08
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 200
Treatments
Active_comparator: Standard of Care
Participants will be provided with continuous Telehealth dietitian follow-up
Experimental: Standard of Care Plus Technology
In addition to standard of care, participants will be provided with gluten detection technology so as to assist in navigating the gluten-free diet.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Columbia University

This content was sourced from clinicaltrials.gov