Actively Recruiting
Gluten Technology and Education for Celiac Health
Led by Columbia University · Updated on 2025-06-27
200
Participants Needed
4
Research Sites
203 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gluten Technology and Education for Celiac Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any gender; Age 18-75 years
- Diagnosed with celiac disease by serology and duodenal biopsy showing Marsh 3 histology with adequate tissue sampling
- Diagnosis made within 4 months prior to initial study screening
- Willing to use gluten detection technology
- Not currently using gluten detection technology testing urine or stool
- Receiving care at one of the four recruitment sites
- Have had an initial dietitian visit at a participating celiac disease center
You will not qualify if you...
- Currently pregnant or planning pregnancy during the study
- Not planning to follow a gluten-free diet
- Participating in a clinical trial of an experimental drug for any condition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
B
Benjamin Lebwohl, MD, MS
CONTACT
R
Randi Wolf, PhD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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