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Behavioral Intervention

Telemedicine + Gluten Detection Tech for Celiac Disease (GLUTECH Trial)

N/A
Waitlist Available
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

GLUTECH Trial 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.Check my eligibility
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.See study design
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.

GLUTECH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with celiac disease through blood tests and a biopsy showing specific changes in my intestine.

GLUTECH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Small Intestinal Healing
Secondary outcome measures
DGP IgA/IgG Level
Intraepithelial Lymphocyte Count (ILC)
Score on PROMIS 29+2
+7 more

GLUTECH Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care Plus TechnologyExperimental Treatment1 Intervention
In addition to standard of care, participants will be provided with gluten detection technologies 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
1,431 Previous Clinical Trials
2,460,631 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
2,356 Previous Clinical Trials
4,314,866 Total Patients Enrolled
3 Trials studying Celiac Disease
254 Patients Enrolled for Celiac Disease
Benjamin Lebwohl, MD, MSPrincipal InvestigatorColumbia University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do participants of this trial need to be below a certain age threshold?

"This experiment is available to individuals aged 18 or higher, but no older than 75."

Answered by AI

Who is eligible to join the research program?

"An individual must be diagnosed with celiac disease and between the ages of 18 to 75 in order to join this trial. 200 individuals will ultimately take part in the clinical study."

Answered by AI

Is this research project in need of additional participants?

"According to information posted on clinicaltrials.gov, this trial is no longer accepting applicants at the present time; it was initially uploaded on November 1st 2023 and last modified September 22nd 2023. Still, 38 other studies are now actively enrolling people into their research program."

Answered by AI

How many settings are administering this experiment?

"There are 4 main sites for this clinical trial, including Beth Israel Deaconess Medical Center in Boston, Columbia University Irving Medical Center in New york, and Vanderbilt University Medical Center in Nashville. In addition to these locations there are other recruitment spots available."

Answered by AI

Who else is applying?

What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Gluten Technology and Education for Celiac Health
Benjamin Lebwohl 2023. "Gluten Technology and Education for Celiac Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06059716.
All > Celiac Disease
~133 spots leftby Aug 2027
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