NCT05186038

Mass Screening for the Early Detection of Patients With Celiac Disease.

Completed Last updated 29 April 2024

What this trial tests

trial testing iVYCHECK GIP Urine in Celiac Disease in 1,000 participants. Completed in 31 December 2022.

Timeline

18 December 2021

Primary endpoint
1 June 2022

31 December 2022

Quick facts

Lead sponsor	Biomedal S.L.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	18 December 2021
Primary completion	1 June 2022
Estimated completion	31 December 2022
Sites	2 locations across Spain

Drugs / interventions tested

• iVYCHECK GIP Urine
• CeliacDetect

Conditions studied

• Celiac Disease — all drugs for Celiac Disease →

Sponsor

Biomedal S.L.

Who can join

Adults 2 to 18, any sex, with Celiac Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The use of a home rapid test for the detection of both gluten immunogenic peptides (GIP) in urine and immunoglobulin A (IgA) anti tissue transglutaminase (anti-tTG) antibodies in blood may contribute to the early detection of volunteers who suffer celiac disease (CD), a highly under-diagnosed disorder. Patients with positive results could inform their doctors in order to accelerate the diagnosis, contribute to symptoms control and improve their quality of life.

This observational, cross-sectional study with no interventions applied in subjects consists on a single group of volunteers between 2 and 18 years old. They will be given an informed consent which must be signed by them or their parents/legal guardians, a Celiac Symptoms Index (CSI) questionnaire and the sample collection material required on the testing day. Urine samples will be collected and analysed in situ or alternatively they will be stored and analyzed after at the laboratory. Blood samples will be collected and analyzed in situ the testing day.

The main outcome is to determine the prevalence of CD through mass screening within the pediatric and adolescent population in order to provide an early diagnosis and avoid long-term consequences which are suffered by untreated patients. As an international innovation, misdiagnosis (false negatives) because of an insufficient gluten intake are expected to be detected, thus the use of GIP detection in urine will confirm gluten ingestion at the diagnosis. Volunteers with a confirmed diagnosis of CD could be monitored by their doctors to corroborate whether a gluten-free diet improves their quality of life.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Rapid Anti-tTG-IgA Screening Test for Early Diagnosis of Celiac Disease in Pediatric Populations.
   Mendia I, Segura V, Ruiz-Carnicer Á, Coto L, et al · · 2023 · cited 3× · PMID 38068784 · DOI 10.3390/nu15234926