Gluten Technology and Education for Celiac Health
GLUTECH
2 other identifiers
interventional
200
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2022
CompletedFirst Posted
Study publicly available on registry
September 29, 2023
CompletedStudy Start
First participant enrolled
October 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
June 27, 2025
April 1, 2025
2.9 years
October 4, 2022
June 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Small Intestinal Healing
This will be measured with a measure in villus height to crypt depth ratio on small intestinal biopsy.
12 months
Secondary Outcomes (10)
Score on the Celiac Dietary Adherence Test (CDAT)
12 months
Score on the Celiac Disease Symptom Diary (CDSD)
12 months
Score on the Celiac-Disease specific Quality of Life (CDQOL)
12 months
Score on PROMIS 29+2
12 months
Score on the State-Trait Anxiety Inventory (STAI)
12 months
- +5 more secondary outcomes
Study Arms (2)
Standard of Care
ACTIVE COMPARATORParticipants will be provided with continuous Telehealth dietitian follow-up
Standard of Care Plus Technology
EXPERIMENTALIn addition to standard of care, participants will be provided with gluten detection technology so as to assist in navigating the gluten-free diet.
Interventions
Portable technology to sense gluten after ingestion
Regular follow-up with an expert dietitian
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Currently pregnant or planning to become pregnant during the study
- Not planning to follow a gluten-free diet
- Concurrent participation in a clinical trial of an experimental pharmacologic agent (for any condition).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Lebwohl, MD, MS
Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 4, 2022
First Posted
September 29, 2023
Study Start
October 8, 2024
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2028
Last Updated
June 27, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Within 1 year of trial publication
- Access Criteria
- Following publication of the trial results, the steering committee may grant access to de-identified data to individuals upon request. This includes the statistical code, questionnaires, and technical processes. The corresponding author of the study will be responsible for conveying the request to the steering committee, communicating with the requestor, and facilitating the transfer of data.
Following publication of the trial results, the steering committee may grant access to de-identified data to individuals upon request. This includes the statistical code, questionnaires, and technical processes. The corresponding author of the study will be responsible for conveying the request to the steering committee, communicating with the requestor, and facilitating the transfer of data.