MedTrace Logo

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

NCT05119322 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-04-29

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

GlutenDetect home urine test

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

Sponsors & Collaborators

  • FUNDACION IHP

    collaborator UNKNOWN

  • Biomedal S.L.

    lead OTHER

Principal Investigators

  • Laura Coto Alonso · Biomedal S.L.

  • Ángel Cebolla Ramírez · Biomedal S.L.

  • Joaquín Reyes Andrade · Fundación IHP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-23
Primary Completion
2022-12-31
Completion
2027-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05119322 on ClinicalTrials.gov