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SCREENING OF CELIAC DISEASE IN SCHOLAR CHILDREN IN ITALY

Sponsor
Università Politecnica delle Marche (Other)
Overall Status
Completed
CT.gov ID
NCT04867863
Collaborator
FONDAZIONE CARIVERONA (Other), Azienda ULSS di Verona e Provincia (Other)
4,570
Enrollment
1
Location
37
Duration (Months)
123.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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)

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    4570 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Study Start Date :
    May 1, 2015
    Actual Primary Completion Date :
    Feb 1, 2016
    Actual Study Completion Date :
    Jun 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. prevalence of celiac serology in children aged 5-10 [2 years]

    Secondary Outcome Measures

    1. prevalence of dental caries in children genetically predisposed to CD in comparison with children not predisposed [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: age 5-10 -

    Exclusion Criteria: celiac disease, on a gluten free diet

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Pediatrics Universita' Politecnica Delle Marche Ancona Italy 60100

    Sponsors and Collaborators

    • Università Politecnica delle Marche
    • FONDAZIONE CARIVERONA
    • Azienda ULSS di Verona e Provincia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carlo Catassi, M.D., PROFESSOR OF PEDIATRICS AND HEAD OF THE DEPARTMENT OF PEDIATRICS, UNIVERSITA POLITECNICA DELLE MARCHE, Università Politecnica delle Marche
    ClinicalTrials.gov Identifier:
    NCT04867863
    Other Study ID Numbers:
    • 121CELIA14
    First Posted:
    Apr 30, 2021
    Last Update Posted:
    Apr 30, 2021
    Last Verified:
    Apr 1, 2021
    Keywords provided by Carlo Catassi, M.D., PROFESSOR OF PEDIATRICS AND HEAD OF THE DEPARTMENT OF PEDIATRICS, UNIVERSITA POLITECNICA DELLE MARCHE, Università Politecnica delle Marche
    celiac disease
    children
    caries
    HLA DQ2
    HLA DQ8
    screening
    Additional relevant MeSH terms:
    Celiac Disease
    Dental Caries

    Study Results

    No Results Posted as of Apr 30, 2021