Clinical trial NCT03321214: Gluten Sensor Device to Promote Gluten Free Diet Adherence and Quality of Life in Patients With Celiac Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Keywords: Gluten Free diet
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life measure
timeFrame: 3 months
Secondary outcomes:
measure: Depression
timeFrame: 3 months
measure: Adherence to the gluten-free diet
timeFrame: 3 months
measure: Celiac disease symptoms
timeFrame: 3 months
measure: Anxiety
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Celiac Disease Center at Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Benjamin Lebwohl, MD,MS
role: PRINCIPAL_INVESTIGATOR
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