Use of a Home Test for Gluten Detection in Urine and Its Effect on Gluten-free Diet Adherence
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Trial details
- Who runs it
- Biomedal S.L.
- Trial code
- NCT05119322
- Record updated
- 29 April 2024
- Original description
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.Read full original descriptionShow less
Study of the Use of a Home Test for the Detection of Gluten Immunogenic Peptides in Urine and Its Effect on Gluten-free Diet Adherence
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).
Inclusion: 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.
Exclusion: Comorbid condition that in the opinion of the investigator would interfere with the study; Not precise diagnostic of CD; 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.