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

Columbia University

Status: Completed

Conditions: Celiac Disease

Treatments: Other: Gluten Sensor Dose-Finding Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03321214

AAAR6004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 13 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals >13 years old (15 teenagers and 15 adults), 30 in total with duodenal biopsy-confirmed diagnosis of celiac disease will be recruited to participate.
• As we are testing a gluten sensor device, we require that participants are 13 years or older as they will need to be able to operate the gluten sensor device independently

Exclusion criteria

• No participants will be excluded based on gender, race or ethnicity.
• Patients diagnosed with celiac disease without a duodenal biopsy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 3 patient groups

Light use of Nima

Experimental group

Description:

Ten participants will be randomized to receive 12 capsules every other month (18 capsules for the 3 months which is considered light use).

Treatment:

Other: Gluten Sensor Dose-Finding Intervention

Moderate use of Nima

Experimental group

Description:

Ten participants will be randomized to receive 12 capsules per month (36 capsules for the 3 months which is considered moderate use).

Treatment:

Other: Gluten Sensor Dose-Finding Intervention

Heavy use of Nima

Experimental group

Description:

Ten participants will be randomized to receive 24 capsules per month (72 capsules for the 3 months which is considered heavy use).

Treatment:

Other: Gluten Sensor Dose-Finding Intervention