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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05186038
Recruitment Status : Recruiting
First Posted : January 11, 2022
Last Update Posted : January 11, 2022
Sponsor:
Collaborators:
University of Seville
FUNDACION IHP
Information provided by (Responsible Party):
Biomedal S.L.

Brief 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.


Condition or disease Intervention/treatment
Celiac Disease Diagnostic Test: iVYCHECK GIP Urine Diagnostic Test: CeliacDetect

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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
Urine and blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Population comprised of patients between 2 and 18 years old who are diagnosed with celiac disease or suspected to suffer the disease. They should have willingness to perform the study and ability to collect urine samples. Moreover, the patients or their legal guardians have to sign the informed consent.
Criteria

Inclusion Criteria:

  • Children and adolescents volunteers (2-18 years old).
  • Regular gluten consumption.
  • Willingness to perform the study and ability to collect urine samples.
  • The signing of the informed consent by the volunteer and his/her legal guardians.

Exclusion Criteria:

  • Related diseases or psychiatric alterations which do not recommend being included in the study as the researcher's consideration.
  • Lack of foreseeable collaboration.
  • Patients which do not provide samples or surveys in 70% of cases.

Information from the National Library of Medicine

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


Contacts
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Contact: Carolina Sousa Martín +34954556452 csoumar@us.es
Contact: Ángel Cebolla Ramírez +34954081276 acebolla@biomedal.com

Locations
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Spain
37th Celiac Festival Completed
Madrid, Spain, 28011
Grupo IHP Recruiting
Seville, Spain, 41014
Contact: Ignacio Salamanca, Dr.       ignaciosalamanca@ihppediatria.com   
Contact: Pilar Fernández       investigacion@ihppediatria.com   
Principal Investigator: Carolina Sousa, Dr.         
Principal Investigator: Ignacio Salamanca, Dr.         
Sub-Investigator: Irati Mendia, MD         
Sponsors and Collaborators
Biomedal S.L.
University of Seville
FUNDACION IHP
Investigators
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Study Chair: Ignacio Salamanca FUNDACION IHP
Publications:

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Responsible Party: Biomedal S.L.
ClinicalTrials.gov Identifier: NCT05186038    
Other Study ID Numbers: CELISIN-02-2020
First Posted: January 11, 2022    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biomedal S.L.:
Mass screening
Diagnosis
Celiac disease
Urine samples
Blood samples
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases