SCREENING OF CELIAC DISEASE IN SCHOLAR CHILDREN IN ITALY

NCT ID: NCT04867863

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4570 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-06-30

Brief Summary

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The main aim of the study is to currently define the prevalence of celiac disease (CD) in children aged 5-10 years in 2 Italian cities (Ancona and Verona). The screening protocol is based on a 1st line genetic test (searche of HLA DQ2/DQ8 genotypes) followed by a serological diagnosis (IgA TTG and IgG DGP).

Detailed Description

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All scholar children aged 5-10 years living in the cities of Ancona and Verona will be invited to partecipate. Children enrolled will be investigated as follows:

1. HLA DQ2/DQ8 genotyping (by a rapid test)
2. In children genetically predisposed to CD serological investigations will be performed (both IgA TTG and IgG DGP antibodies)
3. The overall population will be evaluated for the prevalence and severity of dental caries (by using the DMFT/dmft index)

Conditions

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Celiac Disease Dental Caries

Keywords

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celiac disease children caries HLA DQ2 HLA DQ8 screening

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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FONDAZIONE CARIVERONA

UNKNOWN

Sponsor Role collaborator

Azienda ULSS di Verona e Provincia

OTHER

Sponsor Role collaborator

Università Politecnica delle Marche

OTHER

Sponsor Role lead

Responsible Party

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Carlo Catassi, M.D.

PROFESSOR OF PEDIATRICS AND HEAD OF THE DEPARTMENT OF PEDIATRICS, UNIVERSITA POLITECNICA DELLE MARCHE

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Pediatrics Universita' Politecnica Delle Marche

Ancona, , Italy

Site Status

Countries

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Italy

Other Identifiers

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121CELIA14

Identifier Type: -

Identifier Source: org_study_id