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

April 26, 2024 updated by: Biomedal S.L.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypothesis: the use of a home rapid test for the detection of both gluten immunogenic peptides (GIP) in urine and IgA 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.

Objectives:

Primary objective: to perform a mass screening in the pediatric and adolescent population (2 - 18 years old) in order to assess the prevalence of the CD providing early diagnosis of possible patients through 1 - Detection of IgA anti-tTG antibodies present in blood (to be measured by home rapid tests); 2 - Detection of GIP in urine (to be measured in situ or at a central laboratory).

Specific objectives: 1- To determine the prevalence of CD, particularly in children between 2 and 18 years old; 2 - To detect possible hidden CD cases, avoiding future irreversible damages by a late detection of this pathology such as growth impairment, decalcification, neurotoxicity or risks of suffering other autoimmune diseases; 3 - To detect misdiagnosis (false negatives) because of an insufficient gluten intake, as an international innovation.

Study design: this observational, cross-sectional study with no interventions applied in subjects consists of 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, a short clinical 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.

Study participants: volunteers from the pediatric and adolescent population between 2 and 18 years old. Gluten consumption previous to testing is an innovative requirement in order to validate the IgA anti-tTG antibodies rapid test.

Study procedure:

  1. Patient enrollment.
  2. Testing day: all participants will 1 - return the informed consent signed by them or their parents/legal guardians; 2 - complete the Celiac Symptoms Index (CSI) questionnaire and the clinical questionnaire to check if they have had any previous symptoms or other relevant information to be considered; 3 - collect urine samples in order to determine GIP presence through a immunochromatographic test (iVYCHECK GIP Urine, Biomedal S.L., Seville, Spain) in situ or at the central laboratory, therefore samples will need to be stored. It may be confirmed whether the volunteer was ingesting gluten when the test was performed. - A. If the result is positive, a serological test will be performed at a certified laboratory in order to confirm the volunteer's disease and a specialist to perform the diagnosis will be recommended. Whether the diagnostic is confirmed, five GlutenDetect's units will be given to each diagnosed volunteer to make sure they can check whether the diet is properly followed. - B. If the result is negative, the possibilities of suffering CD are low so any additional test will be performed. Exceptionally, those whose gluten level in urine is undetectable, but their CeliacDetect result appears as negative, a deeper study will be performed about gluten ingestion the day before through 24 hours recall.

Number of participants: a minimum of 1000 volunteers would be needed to achieve a conclusive study in order to determine at least 10 cases of CD. The calculation was made according to CD's prevalence of 1% described by several studies.

Measurements: 1- Laboratory rapid test (iVYCHECK GIP Urine, Biomedal S.L., Seville, Spain) for GIP determination in urine samples and immunochromatographic rapid test (CeliacDetect, Biomedal S.L., Spain) for IgA anti-tTG antibodies detection in blood; 2- CD related symptoms (CSI questionnaire). Urine samples will be analysed in situ or stored and analyzed later at a central laboratory (Biomedal S.L., Seville, Spain).

Statistical analysis: the data obtained in the study will be collected in a data base created with this purpose. Variables are tabulated through the IBM SPSS Statistics V25.0 program from International Business Machines (IBM) (Armonk, New York, USA). Different study variables will be considered: 1 - related to patients (age, gender, parent's study level); 2 - related to the "Celiac symptoms index" questionnaire (presence or not of previous symptomatology); 3 - related to samples (GIP presence in urine and IgA anti-tTG antibodies presence in blood). Each test's result will be considered as significant if the value p<0,05 and very significant if p<0,01. A confidence of 95% will be taken for intervals. When p>0,05, the result will be considered as non-significant.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Carolina Sousa Martín
  • Phone Number: +34954556452
  • Email: csoumar@us.es

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28011
        • 37th Celiac Festival
      • Seville, Spain, 41014
        • Grupo IHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Only the testing day.
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.
Only the testing day.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Only the testing day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biomedal S.L.

Collaborators

University of Seville
FUNDACION IHP

Investigators

  • Study Chair: Ignacio Salamanca, FUNDACION IHP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2021

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

December 23, 2021

First Submitted That Met QC Criteria

December 23, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Estimated)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CELISIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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