RECRUITING

Gluten Technology and Education for Celiac Health

Conditions

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 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.

Official Title

Gluten Technology and Education for Celiac Health

Quick Facts

Study Start:2024-10-08
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06059716

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:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Any gender; Age 18-75 years
  2. * 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
  3. * Diagnosed with celiac disease within 4 months of initial study screening
  4. * Willingness to use gluten-detection technology
  5. * Not currently using a gluten detection technology that tests for gluten in urine or stool
  6. * Seeing a clinician at one of the four recruitment sites
  7. * Having already had an initial dietitian visit at one of the participating celiac disease centers
  1. * Currently pregnant or planning to become pregnant during the study
  2. * Not planning to follow a gluten-free diet
  3. * Concurrent participation in a clinical trial of an experimental pharmacologic agent (for any condition).

Contacts and Locations

Study Contact

Benjamin Lebwohl, MD, MS
CONTACT
212-305-9338
BL114@cumc.columbia.edu
Randi Wolf, PhD, MPH
CONTACT
212-678-3912

Principal Investigator

Benjamin Lebwohl, MD, MS
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Benjamin Lebwohl, MD, MS, PRINCIPAL_INVESTIGATOR, Columbia University

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 Date2024-10-08
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2024-10-08
Study Completion Date2028-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Celiac Disease