Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06059716

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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