Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease

Quality of Life Clinical Trial

Official title:

GlPs Improve Practice (GIP) at Home: Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03462979
• Other study ID #: P00024698
• Status: Suspended
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2022
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate how knowledge of gluten immunogenic peptide (GIP) levels in stool and urine affects subsequent adherence to a gluten-free diet. Half of the participants will receive results in real-time using a home device and the other half will store samples to be tested at the end of the 30 week study. Participants will also have a diet review with a dietitian at the beginning of the end of their study and be asked questions about their symptoms, gluten-free diet adherence and quality of life.

Description:

Following a gluten-free diet is difficult. Eating small amounts of gluten may be common. Gluten may cause a wide range of symptoms, or no symptoms at all. Thus, there is not always a 'feedback loop' to alert to accidental gluten exposure. Nevertheless, these "silent" gluten exposures may interfere with recovery and healing of the intestine. New tools are available to test for fragments of gluten - Gluten Immunogenic Peptides (GIPs) in urine and stool.

The goal of this research study is to evaluate how knowledge of gluten-immunogenic peptide (GIP) levels in urine and stool affects subsequent adherence to a gluten-free diet. Participants will be children with celiac disease recruited at Boston Children's Hospital. All participants will undergo a diet assessment by a dietitian at the beginning and end of the study. At random intervals, participants will be prompted to collect their next urine sample and complete a survey related to symptoms and diet adherence. Half of the participants will store the sample to be tested later and the rest of the participants will be provided with devices to test their urine at home to receive immediate results. Participants in the home testing group will also be given a set of stool tests (x4) to use at their own discretion during the study period, and will report results and reasons for test use to the research team. GIP test results will be compared to other measures of celiac disease and gluten-free diet adherence, including antibody tests. These findings will help to determine how these new tools can be used to improve gluten-free diet adherence and symptoms and the effect on quality of life.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Age 6 to 18 years at study entry

• Diagnosis of celiac disease based upon either

1. Biopsy criteria i) Marsh 3 lesion and/or villous height:crypt depth ratio (Vh:Cd) < 3 with intraepithelial lymphocytosis; and ii) Elevated serum tTG IgA and/or EMA antibodies

2. Serologic/genetic (ESPGHAN 2012) criteria i) Symptoms compatible with celiac disease; ii) Serum tTG IgA > 10 x upper limit of normal for assay; iii) EMA titre elevated on a separate sample; and iv) HLADQ genotype compatible with celiac disease.

• Adherence to a gluten-restricted diet (self-reported) for 6 months or more

• Attending a clinician assessment for celiac disease at Boston Children's Hospital

Exclusion Criteria:

• Unable to provide urine and/or stool sample or attend study visits

• English proficiency unsuitable for completion of surveys

• Anuria or oliguria

• Reliance upon commercial gluten-free formulas as primary source of nutrition

• Comorbid condition that in the opinion of the investigator would interfere with the subject's participation in the study or would confound the results of the study

Related Conditions & MeSH terms

• Celiac Disease
• Diagnostic Self Evaluation
• Diet Modification
• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Gluten Enteropathy
• Gluten Sensitivity
• Intestinal Disease
• Intestinal Diseases
• Malabsorption Syndromes
• Patient Compliance
• Quality of Life

Intervention

Device:
• Immunochromatographic lateral flow test
The immunochromatographic lateral flow test (Gluten Detective) is an at-home test that detects gluten immunogenic peptides excreted in stool or urine. This test can detect gluten exposures which occurred either during the last 24 hours (urine) or within up to a 7 day window (stool). Minimum intake amounts of gluten for successful detection using these test are 50mg (stool) to 500mg (urine)

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	Glutenostics, LLC

Country where clinical trial is conducted

United States, 

References & Publications (10)

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

Comino I, Real A, Vivas S, Síglez MÁ, Caminero A, Nistal E, Casqueiro J, Rodríguez-Herrera A, Cebolla A, Sousa C. Monitoring of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces. Am J Clin Nutr. 2012 Mar;95(3):670-7. doi: 10.3945/ajcn.111.026708. Epub 2012 Jan 18. — View Citation

Lebwohl B, Sanders DS, Green PHR. Coeliac disease. Lancet. 2018 Jan 6;391(10115):70-81. doi: 10.1016/S0140-6736(17)31796-8. Epub 2017 Jul 28. Review. — View Citation

Ludvigsson JF, Ciacci C, Green PH, Kaukinen K, Korponay-Szabo IR, Kurppa K, Murray JA, Lundin KEA, Maki MJ, Popp A, Reilly NR, Rodriguez-Herrera A, Sanders DS, Schuppan D, Sleet S, Taavela J, Voorhees K, Walker MM, Leffler DA. Outcome measures in coeliac disease trials: the Tampere recommendations. Gut. 2018 Aug;67(8):1410-1424. doi: 10.1136/gutjnl-2017-314853. Epub 2018 Feb 13. — View Citation

Moreno ML, Cebolla Á, Muñoz-Suano A, Carrillo-Carrion C, Comino I, Pizarro Á, León F, Rodríguez-Herrera A, Sousa C. Detection of gluten immunogenic peptides in the urine of patients with coeliac disease reveals transgressions in the gluten-free diet and incomplete mucosal healing. Gut. 2017 Feb;66(2):250-257. doi: 10.1136/gutjnl-2015-310148. Epub 2015 Nov 25. — View Citation

Morón B, Bethune MT, Comino I, Manyani H, Ferragud M, López MC, Cebolla A, Khosla C, Sousa C. Toward the assessment of food toxicity for celiac patients: characterization of monoclonal antibodies to a main immunogenic gluten peptide. PLoS One. 2008 May 28;3(5):e2294. doi: 10.1371/journal.pone.0002294. — View Citation

Shan L, Molberg Ø, Parrot I, Hausch F, Filiz F, Gray GM, Sollid LM, Khosla C. Structural basis for gluten intolerance in celiac sprue. Science. 2002 Sep 27;297(5590):2275-9. — 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

van Doorn RK, Winkler LM, Zwinderman KH, Mearin ML, Koopman HM. CDDUX: a disease-specific health-related quality-of-life questionnaire for children with celiac disease. J Pediatr Gastroenterol Nutr. 2008 Aug;47(2):147-52. doi: 10.1097/MPG.0b013e31815ef87d. — View Citation

Varni JW, Burwinkle TM, Seid M. The PedsQL 4.0 as a school population health measure: feasibility, reliability, and validity. Qual Life Res. 2006 Mar;15(2):203-15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in frequency of gluten exposure in open results vs blinded groups following randomization.	Gluten exposure frequency is defined as the average per individual subject post-randomization percentage of samples collected between weeks 8 and 30 with detectable gluten immunogenic peptides using the qualitative assay (Gluten Detective)	Weeks 8 to 30
Secondary	Difference in quantity of mean gluten exposure following randomization in blinded vs. open results groups	Mean gluten exposure is defined as the average per individual subject post-randomization concentration of gluten immunogenic peptides detected using the quantitative assay	weeks 8 - 30
Secondary	Celiac disease symptom score in blinded vs. open results group at the end of the study	Symptom score (using the Celiac Disease PedsRO or ObsRO as appropriate for age) at week 30	Week 30
Secondary	Change in symptom score in blinded vs. open results group	Symptom score (using the Celiac Disease PedsRO or ObsRO as appropriate) and the change in symptom score between the end of the run-in period (week 8) and the end of the study period (week 30) will be calculated arithmetically.	weeks 8 and 30
Secondary	Change in celiac disease specific quality of life as measured by Celiac Disease DUX (CDDUX) in blinded vs. open results groups	The CDDUX is a disease specific quality of life instrument for children with celiac disease.	weeks 8 and 30
Secondary	Change in pediatric health related quality of life as measured by PedsQL 4.0 generic core scale in blinded vs. open results groups	The PedsQL 4.0 Generic Core is a validated pediatric general quality of life measure that is caregiver reported for younger children and both child and caregiver reported for older children. The score is scaled from 0 (lowest) to 100 (highest) with higher scores corresponding to better health related quality of life.	weeks 8 and 30