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

Celiac Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03321214
• Other study ID #: AAAR6004
• Status: Completed
• Phase: N/A
• Start date: January 2, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: January 2020
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Celiac Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Celiac Disease Center at Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (10)

Abu Daya H, Lebwohl B, Lewis SK, Green PH. Celiac disease patients presenting with anemia have more severe disease than those presenting with diarrhea. Clin Gastroenterol Hepatol. 2013 Nov;11(11):1472-7. doi: 10.1016/j.cgh.2013.05.030. Epub 2013 Jun 10. — View Citation

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. — View Citation

Green PH, Krishnareddy S, Lebwohl B. Clinical manifestations of celiac disease. Dig Dis. 2015;33(2):137-40. doi: 10.1159/000370204. Epub 2015 Apr 22. Review. — View Citation

Hall NJ, Rubin G, Charnock A. Systematic review: adherence to a gluten-free diet in adult patients with coeliac disease. Aliment Pharmacol Ther. 2009 Aug 15;30(4):315-30. doi: 10.1111/j.1365-2036.2009.04053.x. Epub 2009 May 26. Review. — View Citation

Lebwohl B, Granath F, Ekbom A, Smedby KE, Murray JA, Neugut AI, Green PH, Ludvigsson JF. Mucosal healing and risk for lymphoproliferative malignancy in celiac disease: a population-based cohort study. Ann Intern Med. 2013 Aug 6;159(3):169-75. doi: 10.7326/0003-4819-159-3-201308060-00006. — View Citation

Lohi S, Mustalahti K, Kaukinen K, Laurila K, Collin P, Rissanen H, Lohi O, Bravi E, Gasparin M, Reunanen A, Mäki M. Increasing prevalence of coeliac disease over time. Aliment Pharmacol Ther. 2007 Nov 1;26(9):1217-25. — View Citation

Meyer D, Stavropolous S, Diamond B, Shane E, Green PH. Osteoporosis in a north american adult population with celiac disease. Am J Gastroenterol. 2001 Jan;96(1):112-9. — View Citation

Rubio-Tapia A, Kyle RA, Kaplan EL, Johnson DR, Page W, Erdtmann F, Brantner TL, Kim WR, Phelps TK, Lahr BD, Zinsmeister AR, Melton LJ 3rd, Murray JA. Increased prevalence and mortality in undiagnosed celiac disease. Gastroenterology. 2009 Jul;137(1):88-93. doi: 10.1053/j.gastro.2009.03.059. Epub 2009 Apr 10. — View Citation

Rubio-Tapia A, Ludvigsson JF, Brantner TL, Murray JA, Everhart JE. The prevalence of celiac disease in the United States. Am J Gastroenterol. 2012 Oct;107(10):1538-44; quiz 1537, 1545. doi: 10.1038/ajg.2012.219. Epub 2012 Jul 31. — View Citation

Silvester JA, Graff LA, Rigaux L, Walker JR, Duerksen DR. Symptomatic suspected gluten exposure is common among patients with coeliac disease on a gluten-free diet. Aliment Pharmacol Ther. 2016 Sep;44(6):612-9. doi: 10.1111/apt.13725. Epub 2016 Jul 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life measure	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).	3 months
Secondary	Depression	The 21 item Beck Depression Inventory (BDI). This depression scale ranges from 0 (fewer symptoms) to 60 (most symptoms).	3 months
Secondary	Adherence to the gluten-free diet	A 7-item validated CD adherence test (CDAT) survey. Higher scores suggest worse adherence (with scores >13 indicative of poor adherence)	3 months
Secondary	Celiac disease symptoms	Celiac Disease Symptom Diary (CDSD)	3 months
Secondary	Anxiety	21 item Beck Anxiety Inventory. This anxiety index ranges from 20 (lower anxiety) to 100 (greater anxiety).	3 months

External Links

•   Gluten sensor device website