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Behavioral Intervention
Telemedicine + Gluten Detection Tech for Celiac Disease (GLUTECH Trial)
N/A
Recruiting
Led By Benjamin Lebwohl, MD, MS
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test a new way to manage celiac disease, potentially improving recovery and reducing the physical and psychological impact of the disease.
Who is the study for?
Adults aged 18-75, recently diagnosed with celiac disease, who are willing to use gluten-detection technology and have had an initial dietitian visit at a participating center. They must not be pregnant or planning pregnancy during the study nor involved in another drug trial.
What is being tested?
The effectiveness of using gluten detection technologies alongside telemedicine for managing celiac disease is being tested. This randomized controlled trial aims to see if this approach helps patients recover better and cope with the condition's challenges.
What are the potential side effects?
Since the interventions involve non-invasive monitoring and technology use rather than medication, typical drug side effects are not expected. However, there may be indirect effects related to lifestyle adjustments due to continuous monitoring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with celiac disease through blood tests and a biopsy showing specific changes in my intestine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Small Intestinal Healing
Secondary study objectives
DGP IgA/IgG Level
Intraepithelial Lymphocyte Count (ILC)
Score on PROMIS 29+2
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care Plus TechnologyExperimental Treatment2 Interventions
In addition to standard of care, participants will be provided with gluten detection technology so as to assist in navigating the gluten-free diet.
Group II: Standard of CareActive Control1 Intervention
Participants will be provided with continuous Telehealth dietitian follow-up
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,498 Previous Clinical Trials
2,766,925 Total Patients Enrolled
2 Trials studying Celiac Disease
80 Patients Enrolled for Celiac Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,463 Previous Clinical Trials
4,337,203 Total Patients Enrolled
3 Trials studying Celiac Disease
254 Patients Enrolled for Celiac Disease
Benjamin Lebwohl, MD, MSPrincipal InvestigatorColumbia University