Clinical trial NCT06059716: Gluten Technology and Education for Celiac Health
Official title: Gluten Technology and Education for Celiac Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Celiac Disease
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-09-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The proposed project addresses the need for a rigorous trial to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in adults. Celiac disease affects about 1% of the United States (U.S.) population and seroprevalence has increased up to 5-fold in the U.S. since the 1950's, with diagnosis rates continuing to rise. Morbidity can be severe and includes anemia, infertility, osteoporosis, and malignancies, which can increase all-cause mortality. The only proven therapy is a strict gluten-free diet, the management of which can be extremely challenging and has been linked to diminished quality of life, including anxiety, depression, and fatigue. Despite the recommendation to see a dietitian regularly, many with celiac disease do not see one at all or have only a single session immediately post-diagnosis. The COVID-19 pandemic has catalyzed the rapid adoption of telemedicine in gastroenterology and can facilitate communication between patient and dietitian by eliminating the need to arrange face-to-face meetings at celiac disease centers, which may be at great distance. Self-monitoring with new technologies for gluten detection in urine (e.g., gluten immunogenic peptide kits) can facilitate greater individual awareness of gluten exposures, are commercially available to the public, and have been shown to be valid and reliable. Physicians and dietitians are being asked if this technology should be used, and our preliminary studies have demonstrated acceptability and feasibility, but their impact on clinical outcomes such as mucosal recovery and symptoms has not been established. This U01 proposal is for a multi-center (New York, Massachusetts, Illinois, Tennessee) randomized controlled trial (M-RCT) to assess the effectiveness and document costs of gluten detection technologies as an adjunct to telemedicine on behavioral and clinical outcomes among newly diagnosed patients with celiac disease. Participants will be randomized to receive either 1) standard of care (i.e. a one-time in-person dietitian session plus telemedicine dietitian follow-up; or 2) standard of care + gluten detection technology. This would be the first large-scale clinical trial to test the effect of self-monitoring using gluten detection technology in the management of celiac disease. The primary outcome will be mucosal recovery 12-months post-randomization. Secondary outcomes include change in gastrointestinal symptoms, diet adherence, quality of life (including anxiety and depression), eating behaviors, intraepithelial lymphocyte counts on histology, and celiac disease serology, all assessed at baseline and again at 12-months post-randomization. If the primary endpoint of this proposed U01 is met, the 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Small Intestinal Healing
timeFrame: 12 months
Secondary outcomes:
measure: Score on the Celiac Dietary Adherence Test (CDAT)
timeFrame: 12 months
measure: Score on the Celiac Disease Symptom Diary (CDSD)
timeFrame: 12 months
measure: Score on the Celiac-Disease specific Quality of Life (CDQOL)
timeFrame: 12 months
measure: Score on PROMIS 29+2
timeFrame: 12 months
measure: Score on the State-Trait Anxiety Inventory (STAI)
timeFrame: 12 months
measure: Score on the Center for Epidemiologic Studies Depression Scale for adults (CESD-R)
timeFrame: 12 months
measure: Score on the CD-FAB
timeFrame: 12 months
measure: Intraepithelial Lymphocyte Count (ILC)
timeFrame: 12 months
measure: Tissue Transglutaminase IgA (TTG-IgA) Level
timeFrame: 12 months
measure: DGP IgA/IgG Level
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Columbia University
name: Benjamin Lebwohl, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: