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Trial record 8 of 37 for:    Recruiting, Not yet recruiting, Available Studies | "Malabsorption Syndromes" | United States

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

This study is not yet open for participant recruitment.
Verified October 2017 by Benjamin Lebwohl, Columbia University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03321214
First Posted: October 25, 2017
Last Update Posted: October 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Benjamin Lebwohl, Columbia University
  Purpose

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.


Condition Intervention
Celiac Disease Device: Gluten Sensor Device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Benjamin Lebwohl, Columbia University:

Primary Outcome Measures:
  • Quality of life measure [ Time Frame: 3 months ]
    A 20-item Celiac Disease-Quality of Life (CD-QOL) survey or 17-item Celiac Disease Pediatric Quality of (CDPQOL) survey. Each of these scales ranges from a minimum of 0 (lowest quality of life) to 100 (highest quality of life).


Secondary Outcome Measures:
  • Depression [ Time Frame: 3 months ]
    The 21 item Beck Depression Inventory (BDI). This depression scale ranges from 0 (fewer symptoms) to 60 (most symptoms).

  • Adherence to the gluten-free diet [ Time Frame: 3 months ]
    A 7-item validated CD adherence test (CDAT) survey. Higher scores suggest worse adherence (with scores >13 indicative of poor adherence)

  • Celiac disease symptoms [ Time Frame: 3 months ]
    Celiac Disease Symptom Diary (CDSD)

  • Anxiety [ Time Frame: 3 months ]
    21 item Beck Anxiety Inventory. This anxiety index ranges from 20 (lower anxiety) to 100 (greater anxiety).


Estimated Enrollment: 30
Anticipated Study Start Date: December 1, 2017
Estimated Study Completion Date: December 1, 2018
Estimated Primary Completion Date: June 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Light use of Nima
Ten participants will be randomized to receive 12 capsules every other month (18 capsules for the 3 months which is considered light use).
Device: Gluten Sensor Device

Gluten Sensor Device 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. Ten participants will be randomized to receive 24 capsules per month; ten participants will be randomized to receive 12 capsules per month; and ten participants will be randomized to receive 12 capsules every other month. 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.

Other Name: Nima
Experimental: Moderate use of Nima
Ten participants will be randomized to receive 12 capsules per month (36 capsules for the 3 months which is considered moderate use).
Device: Gluten Sensor Device

Gluten Sensor Device 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. Ten participants will be randomized to receive 24 capsules per month; ten participants will be randomized to receive 12 capsules per month; and ten participants will be randomized to receive 12 capsules every other month. 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.

Other Name: Nima
Experimental: Heavy use of Nima
Ten participants will be randomized to receive 24 capsules per month (72 capsules for the 3 months which is considered heavy use).
Device: Gluten Sensor Device

Gluten Sensor Device 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. Ten participants will be randomized to receive 24 capsules per month; ten participants will be randomized to receive 12 capsules per month; and ten participants will be randomized to receive 12 capsules every other month. 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.

Other Name: Nima

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03321214


Contacts
Contact: Benjamin Lebwohl, MD,MS (212)305-5590 bl114@cumc.columbia.edu
Contact: Randi Wolf, Ph.D., MPH (212) 678-3912 rlw118@tc.columbia.edu

Locations
United States, New York
Celiac Disease Center at Columbia University Not yet recruiting
New York, New York, United States, 10032
Contact: Benjamin Lebwohl, MD,MS    212-305-5590      
Principal Investigator: Benjamin Lebwohl, MD,MS         
Sub-Investigator: Randi Wolf, Ph.D.,MPH         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Benjamin Lebwohl, MD,MS Columbia University
  More Information

Additional Information:
Publications:
Comino I, Fernández-Bañares F, Esteve M, Ortigosa L, Castillejo G, Fambuena B, Ribes-Koninckx C, Sierra C, Rodríguez-Herrera A, Salazar JC, Caunedo Á, Marugán-Miguelsanz JM, Garrote JA, Vivas S, Lo Iacono O, Nuñez A, Vaquero L, Vegas AM, Crespo L, Fernández-Salazar L, Arranz E, Jiménez-García VA, Antonio Montes-Cano M, Espín B, Galera A, Valverde J, Girón FJ, Bolonio M, Millán A, Cerezo FM, Guajardo C, Alberto JR, Rosinach M, Segura V, León F, Marinich J, Muñoz-Suano A, Romero-Gómez M, Cebolla Á, Sousa C. Fecal Gluten Peptides Reveal Limitations of Serological Tests and Food Questionnaires for Monitoring Gluten-Free Diet in Celiac Disease Patients. Am J Gastroenterol. 2016 Oct;111(10):1456-1465. doi: 10.1038/ajg.2016.439. Epub 2016 Sep 20. Erratum in: Am J Gastroenterol. 2017 Jul;112(7):1208.

Responsible Party: Benjamin Lebwohl, Herbert Irving Assistant Professor of Medicine and Assistant Professor of Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT03321214     History of Changes
Other Study ID Numbers: AAAR6004
First Submitted: October 20, 2017
First Posted: October 25, 2017
Last Update Posted: October 30, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Benjamin Lebwohl, Columbia University:
Gluten Free diet

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases