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

NCT03321214 | Completed

• 1 other identifier: AAAR6004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Keywords

Gluten Free diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Depression

  3 months

• Adherence to the gluten-free diet

  3 months

• Celiac disease symptoms

  3 months

• Anxiety

  3 months

Study Arms (3)

Light use of Nima

EXPERIMENTAL

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

Other: Gluten Sensor Dose-Finding Intervention

Moderate use of Nima

EXPERIMENTAL

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

Other: Gluten Sensor Dose-Finding Intervention

Heavy use of Nima

EXPERIMENTAL

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

Other: Gluten Sensor Dose-Finding Intervention

Interventions

Gluten Sensor Dose-Finding Intervention OTHER

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.

Also known as: Nima

Heavy use of Nima; Light use of Nima; Moderate use of Nima

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Celiac Disease Center at Columbia University

New York, New York, 10032, United States

Location

Related Publications (12)

• Green PHR, Krishnareddy S, Lebwohl B. Clinical manifestations of celiac disease. Dig Dis. 2015;33(2):137-140. doi: 10.1159/000370204. Epub 2015 Apr 22.

  PMID: 25925914 BACKGROUND

• 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.

  PMID: 23756221 BACKGROUND

• 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.

  PMID: 19362553 BACKGROUND

• 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.

  PMID: 22850429 BACKGROUND

• Lohi S, Mustalahti K, Kaukinen K, Laurila K, Collin P, Rissanen H, Lohi O, Bravi E, Gasparin M, Reunanen A, Maki M. Increasing prevalence of coeliac disease over time. Aliment Pharmacol Ther. 2007 Nov 1;26(9):1217-25. doi: 10.1111/j.1365-2036.2007.03502.x.

  PMID: 17944736 BACKGROUND

• 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. doi: 10.1111/j.1572-0241.2001.03507.x.

  PMID: 11197239 BACKGROUND

• 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.

  PMID: 23922062 BACKGROUND

• 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.

  PMID: 19485977 BACKGROUND

• Comino I, Fernandez-Banares F, Esteve M, Ortigosa L, Castillejo G, Fambuena B, Ribes-Koninckx C, Sierra C, Rodriguez-Herrera A, Salazar JC, Caunedo A, Marugan-Miguelsanz JM, Garrote JA, Vivas S, Lo Iacono O, Nunez A, Vaquero L, Vegas AM, Crespo L, Fernandez-Salazar L, Arranz E, Jimenez-Garcia VA, Antonio Montes-Cano M, Espin B, Galera A, Valverde J, Giron FJ, Bolonio M, Millan A, Cerezo FM, Guajardo C, Alberto JR, Rosinach M, Segura V, Leon F, Marinich J, Munoz-Suano A, Romero-Gomez M, Cebolla A, 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.

  PMID: 27644734 BACKGROUND

• 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.

  PMID: 27443825 BACKGROUND

• Wolf RL, Vipperman-Cohen A, Green PHR, Lee AR, Reilly NR, Zybert P, Lebwohl B. Portable gluten sensors: qualitative assessments by adults and adolescents with coeliac disease. J Hum Nutr Diet. 2020 Dec;33(6):876-880. doi: 10.1111/jhn.12810. Epub 2020 Sep 25.

  PMID: 32975829 DERIVED

• Wolf RL, Green PHR, Lee AR, Reilly NR, Zybert P, Lebwohl B. Benefits From and Barriers to Portable Detection of Gluten, Based on a Randomized Pilot Trial of Patients With Celiac Disease. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2605-2607. doi: 10.1016/j.cgh.2019.03.011. Epub 2019 Mar 15.

  PMID: 30885882 DERIVED

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Benjamin Lebwohl, MD,MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 25, 2017
• Study Start: January 2, 2018
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

US (1)