Scrutiny Based in a Novel Test to Help the Early Detection of Celiac Disease.

Detailed Summary

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.

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