NCT03321214

Gluten Sensor Device to Promote Gluten Free Diet Adherence and Quality of Life in Patients With Celiac Disease

A Pilot Study to Test the Feasibility and Acceptability of Using a Gluten Sensor Device to Promote Gluten Free Diet Adherence and Quality of Life in Patients With Celiac Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 13 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The current treatment for celiac disease is a strict 100% gluten free diet. Little is known about the best way to promote adherence to such a strict diet and how to maximize quality of life at the same time. This pilot will look at the utility of a new innovation to promote gluten free diet adherence - a portable gluten sensor device. Participants will be 30 teenagers and adults with celiac disease recruited from the Celiac Disease Center at Columbia University in New York City. Before and after the intervention, participants will be asked about their adherence to a gluten free diet, quality of life, symptoms, and feelings of anxiety, and depression. This pilot data will help to inform interventions that the investigators hope to test in a larger NIH-funded trial to better understand the best ways to promote adherence and quality of life in celiac patients.

Detailed description

Little is known about the best ways to promote a strict gluten-free diet while maximizing quality of life in teenagers and adults with celiac disease. The aim of the proposed pilot is to assess the acceptability and feasibility of a novel intervention - a portable gluten sensor device. The sample for this pilot will be 30 teenagers and adults with biopsy confirmed celiac disease recruited from the Celiac Center at Columbia University in New York City. Thirty participants will pilot test a portable gluten sensor device with its associated iPhone app for 3 months. At baseline and three-month follow-up, participants will complete measures of gluten free diet adherence, quality of life,symptoms, anxiety, and depression. At post-only, the investigators will collect in-depth data related to the feasibility and acceptability of the gluten sensor, as well as facilitators and barriers related to how, where, and when it was used. At the completion of the proposed pilot study, the investigators hope to have preliminary data to inform development of gluten sensor interventions that the investigators hope to test in a larger NIH-funded randomized controlled trial. These findings, in combination with a larger trial, have the potential for the development of a new standard of care in the management of patients with celiac disease.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
OTHER	Gluten Sensor Dose-Finding Intervention	Nima is a small portable sensor that detects gluten in a small amount of liquid and solid foods in about three minutes. Nima combines an electronic sensor with antibody-based detection in a disposable capsule. Nima displays a "smiley face" if the food or beverage is \< 20 ppm or a wheat icon for \> 20 ppm (low or high gluten). Each of the 30 participants will receive a Nima along with 3 months of disposable capsules. At the baseline visit, research staff will provide participants with the Nima and capsules and review instructions on how to properly use the device with all participants.

Timeline

• Start date: 2018-01-02
• Primary completion: 2018-10-31
• Completion: 2018-10-31
• First posted: 2017-10-25
• Last updated: 2020-01-07

Locations

1 site across 1 country: United States