Mass Screening for the Early Detection of Patients With Celiac Disease.
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|ClinicalTrials.gov Identifier: NCT05186038|
Recruitment Status : Recruiting
First Posted : January 11, 2022
Last Update Posted : January 11, 2022
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.
|Condition or disease||Intervention/treatment|
|Celiac Disease||Diagnostic Test: iVYCHECK GIP Urine Diagnostic Test: CeliacDetect|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Scrutiny Based in a Novel Test to Help the Early Detection of Celiac Disease.|
|Actual Study Start Date :||December 18, 2021|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Population of children and adolescents between 2 and 18 years old
Population of children and adolescents between 2 and 18 years old who are diagnosed with celiac disease or are suspected to suffer the disease.
Diagnostic Test: iVYCHECK GIP Urine
To determine the presence of Gluten Immunogenic Peptides (GIP) in urine samples using the immunochromatographic test iVYCHECK GIP Urine (Biomedal S.L).
Diagnostic Test: CeliacDetect
To determine the presence of IgA anti-tTG antibodies in blood samples using the immunochromatographic test CeliacDetect (Biomedal S.L).
- Presence of Gluten Immunogenic Peptide (GIP) in urine [ Time Frame: Only the testing day. ]The immunochromatographic test iVYCHECK GIP Urine allows the detection of GIP resulting from gastrointestinal degradation of ingested gluten in urine. The detection step is based on the reaction of the 33-mer-like immunogenic peptides of gluten present in the sample with the coloured conjugated (monoclonal anti-gliadin 33-mer antibody/red-coloured microsphere) previously loaded in the cassette. Complexes spread through the cassette by capillarity and interact with a second anti-gliadin 33-mer antibody immobilized on the membrane at the test zone. A red line at the test zone indicates a positive result while the absence of the red line indicates a negative result.
- Presence of IgA anti-tTG in blood [ Time Frame: Only the testing day. ]The immunochromatographic test CeliacDetect allows the detection of IgA anti-tTG in blood samples. The detection step is based on the union of the IgA anti-tTG with anti human IgA antibodies labeled with colloidal gold and tTG (whose origin is the erythrocyte lysis in the dilution buffer). The complex would be bounded to the stable protein line (test line) by tTG. A red line at the test zone indicates a positive result while the absence of the red line indicates a negative result.
- Presence of previous symptoms [ Time Frame: Only the testing day. ]Number of participants with CD symptoms previously to the study as assessed by Celiac Symptoms Index (CSI) questionnaire. The scores on the CSI are recoded into a scale from 16 to 80. A score of ≥38 is considered as symptomatic.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05186038
|Contact: Carolina Sousa Martínfirstname.lastname@example.org|
|Contact: Ángel Cebolla Ramírezemail@example.com|
|37th Celiac Festival||Completed|
|Madrid, Spain, 28011|
|Seville, Spain, 41014|
|Contact: Ignacio Salamanca, Dr. firstname.lastname@example.org|
|Contact: Pilar Fernández email@example.com|
|Principal Investigator: Carolina Sousa, Dr.|
|Principal Investigator: Ignacio Salamanca, Dr.|
|Sub-Investigator: Irati Mendia, MD|
|Study Chair:||Ignacio Salamanca||FUNDACION IHP|