Use of a Home Test for Gluten Detection in Urine and Its Effect on Gluten-free Diet Adherence

NCT05119322 | Suspended

• 1 other identifier: GLUTENDETECT
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The use of a home rapid test for the detection of gluten immunogenic peptides (GIP) in urine of treated adolescent patients with celiac disease (CD) could facilitate the adherence to the gluten-free diet (GFD) and contribute to symptoms control and quality of life improvement. This single centre, randomized, unblinded, controlled study consists of 4 run-in weeks period followed by 8-weeks study period in which patients will be randomized to intervention group (home urine GIP testing) or the control group (no home urine GIP testing). The 12-week study will involve surveys, home stool and urine collection, home urine GIP test performance, and two study visits with the gastroenterologists. The main outcome is to determine whether the self-monitoring of the GFD with GIP testing in urine improves adherence to the GFD in treated adolescent patients with CD (measured by CDAT-Celiac Dietary Adherence Test, GFD adherence evaluation by gastroenterologist and rates of gluten exposure in urine and/or stool measured at a central laboratory) and subsequently improves quality of life (CDDUX-Coeliac Disease Dutch Questionnaire) and reduces symptoms (CSI-Celiac Symptoms Index questionnaire).

Conditions

Celiac Disease; Treatment Adherence; Adolescent

Keywords

Celiac disease; Gluten-free diet adherence; Adolescent; Gluten immunogenic peptides; Urine tests

Outcome Measures

Primary Outcomes (4)

• Gluten-free adherence change

  Number of participants adherent to GFD in intervention and control arms as assessed by Celiac Dietary Adherence Test (CDAT), change from baseline in scores on the test after 8 weeks of intervention. The scores on the CDAT have a scale from 7 to 35. A score of \<13 is considered as good diet adherence and a score \>17 is considered as bad diet adherence.

  8 weeks

• Gluten-free adherence change

  Number of participants adherent to GFD in intervention and control arms as assessed by GFD adherence evaluation questionnaire by gastroenterologist, change from baseline in level of diet adherence on the questionnaire after 8 weeks of intervention. The scores have a scale from 0 to 32 and social questions (5) have a yes/no answer. A score of 0-7 and "no" in all social questions is considered excellent diet adherence; a score of 8-15 and "no" in all social questions is considered good diet adherence; a score of 8-15 and "yes" in one social question is considered regular diet adherence; a score of 16-24 and "yes" in two social questions is considered regular diet adherence; a score of 16-24 and "yes" in three social questions is considered bad diet adherence; a score of 25-32 and "yes" in two social questions is considered bad diet adherence; a score of 25-32 and "yes" in three social questions is considered very bad diet adherence.

  8 weeks

• Gluten-free adherence change

  Number of participants adherent to GFD in intervention and control arms as assessed by detection of GIP in urine and/or stool samples (measured at a central laboratory), change from baseline in GIP qualitative and quantitative results after 8 weeks of intervention.

  8 weeks

• Gluten-free adherence change

  Number of participants adherent to GFD in intervention group as assessed by detection of GIP in urine samples (measured by home rapid tests), change from baseline in GIP qualitative results after 8 weeks of intervention.

  8 weeks

Secondary Outcomes (2)

• Quality of life change

  8 weeks

• Symptoms change

  8 weeks

Study Arms (2)

GlutenDetect home urine test

EXPERIMENTAL

The GlutenDetect home urine test group will receive home use tests for GIP detection in urine to self-monitor the GFD. Tests will be used at their discretion, but using at least 8 tests during the study period (1/week), so that they may receive immediate qualitative feedback regarding the presence of biomarkers of gluten exposure in their urine and they will have to register the results obtained. Additionally, patients will collect a urine and a stool sample every 4 weeks to evaluate their adherence to the GFD in the laboratory.

Diagnostic Test: GlutenDetect home urine test

Control group

NO INTERVENTION

The control group will not receive any home urine tests but will collect a urine and a stool sample every 4 weeks with the purpose of evaluating their adherence to the GFD in the laboratory.

Interventions

GlutenDetect home urine test DIAGNOSTIC_TEST

GFD compliance self-asessment using a home rapid test for GIP detection in urine.

GlutenDetect home urine test

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Willingness to take part in the study.
• Signed informed consent.
• Diagnosis of CD confirmed by biopsy and/or serology.
• Ability to: provide urine and stool samples, perform the home tests, and register results.

You may not qualify if:

• Not precise diagnostic of CD.
• Comorbid condition that in the opinion of the investigator would interfere with the study.
• Lack of willingness to take part in the study.
• Inability to use the test or provide samples.
• Frequent voluntary GFD transgressions.
• To provide less than 70% of the required samples.

Sponsors & Collaborators

• Biomedal S.L.: lead
• FUNDACION IHP: collaborator

Study Sites (1)

Grupo IHP

Seville, 41013, Spain

Location

Related Publications (6)

• Comino I, Real A, Vivas S, Siglez MA, Caminero A, Nistal E, Casqueiro J, Rodriguez-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.

  PMID: 22258271 BACKGROUND

• Moreno ML, Cebolla A, Munoz-Suano A, Carrillo-Carrion C, Comino I, Pizarro A, Leon F, Rodriguez-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.

  PMID: 26608460 BACKGROUND

• Gerasimidis K, Zafeiropoulou K, Mackinder M, Ijaz UZ, Duncan H, Buchanan E, Cardigan T, Edwards CA, McGrogan P, Russell RK. Comparison of Clinical Methods With the Faecal Gluten Immunogenic Peptide to Assess Gluten Intake in Coeliac Disease. J Pediatr Gastroenterol Nutr. 2018 Sep;67(3):356-360. doi: 10.1097/MPG.0000000000002062.

  PMID: 29916953 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

• Costa AF, Sugai E, Temprano MP, Niveloni SI, Vazquez H, Moreno ML, Dominguez-Flores MR, Munoz-Suano A, Smecuol E, Stefanolo JP, Gonzalez AF, Cebolla-Ramirez A, Maurino E, Verdu EF, Bai JC. Gluten immunogenic peptide excretion detects dietary transgressions in treated celiac disease patients. World J Gastroenterol. 2019 Mar 21;25(11):1409-1420. doi: 10.3748/wjg.v25.i11.1409.

  PMID: 30918433 BACKGROUND

• Comino I, Segura V, Ortigosa L, Espin B, Castillejo G, Garrote JA, Sierra C, Millan A, Ribes-Koninckx C, Roman E, Rodriguez-Herrera A, Diaz J, Silvester JA, Cebolla A, Sousa C. Prospective longitudinal study: use of faecal gluten immunogenic peptides to monitor children diagnosed with coeliac disease during transition to a gluten-free diet. Aliment Pharmacol Ther. 2019 Jun;49(12):1484-1492. doi: 10.1111/apt.15277. Epub 2019 May 10.

  PMID: 31074004 BACKGROUND

Related Links

• GlutenDetect website
• iVYDAL website

MeSH Terms

Conditions

Celiac Disease; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

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

Study Officials

• Laura Coto Alonso

  Biomedal S.L.

  PRINCIPAL INVESTIGATOR

• Ángel Cebolla Ramírez

  Biomedal S.L.

  STUDY DIRECTOR

• Joaquín Reyes Andrade

  Fundación IHP

  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

Model Details: Intervention and control groups

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 15, 2021
• Study Start: March 23, 2021
• Primary Completion: December 31, 2022
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)