---
title: Gluten Technology and Education for Celiac Health
nct_id: NCT06059716
overall_status: RECRUITING
phase: NA
sponsor: Columbia University
study_type: INTERVENTIONAL
primary_condition: Celiac Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06059716.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06059716"
ct_last_update_post_date: 2025-06-27
last_seen_at: "2026-05-12T07:27:24.914Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Gluten Technology and Education for Celiac Health

**NCT ID:** [NCT06059716](https://clinicaltrials.gov/study/NCT06059716)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** Columbia University
- **Collaborators:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- **Conditions:** Celiac Disease
- **Start Date:** 2024-10-08
- **Completion Date:** 2028-08-31
- **CT.gov Last Update:** 2025-06-27

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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).
```

## Arms

- **Standard of Care** (ACTIVE_COMPARATOR) — Participants will be provided with continuous Telehealth dietitian follow-up
- **Standard of Care Plus Technology** (EXPERIMENTAL) — In addition to standard of care, participants will be provided with gluten detection technology so as to assist in navigating the gluten-free diet.

## Interventions

- **Gluten detection technology** (BEHAVIORAL) — Portable technology to sense gluten after ingestion
- **Continuous telemedicine monitoring** (BEHAVIORAL) — Regular follow-up with an expert dietitian

## Primary Outcomes

- **Small Intestinal Healing** _(time frame: 12 months)_ — This will be measured with a measure in villus height to crypt depth ratio on small intestinal biopsy.

## Secondary Outcomes

- **Score on the Celiac Dietary Adherence Test (CDAT)** _(time frame: 12 months)_
- **Score on the Celiac Disease Symptom Diary (CDSD)** _(time frame: 12 months)_
- **Score on the Celiac-Disease specific Quality of Life (CDQOL)** _(time frame: 12 months)_
- **Score on PROMIS 29+2** _(time frame: 12 months)_
- **Score on the State-Trait Anxiety Inventory (STAI)** _(time frame: 12 months)_
- **Score on the Center for Epidemiologic Studies Depression Scale for adults (CESD-R)** _(time frame: 12 months)_
- **Score on the CD-FAB** _(time frame: 12 months)_
- **Intraepithelial Lymphocyte Count (ILC)** _(time frame: 12 months)_
- **Tissue Transglutaminase IgA (TTG-IgA) Level** _(time frame: 12 months)_
- **DGP IgA/IgG Level** _(time frame: 12 months)_

## Locations (4)

- University of Chicago Medical Center, Chicago, Illinois, United States — _RECRUITING_
- Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States — _RECRUITING_
- Columbia University Irving Medical Center, New York, New York, United States — _RECRUITING_
- Vanderbilt University Medical Center, Nashville, Tennessee, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of chicago medical center|chicago|illinois|united states` — added _(2026-05-12)_
- `locations.beth israel deaconess medical center|boston|massachusetts|united states` — added _(2026-05-12)_
- `locations.columbia university irving medical center|new york|new york|united states` — added _(2026-05-12)_
- `locations.vanderbilt university medical center|nashville|tennessee|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06059716.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06059716*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*