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OpenTrials
Completed

NCT Number: NCT04867863

SCREENING OF CELIAC DISEASE IN SCHOLAR CHILDREN IN ITALY

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).

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Key information

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pediatrics Universita' Politecnica Delle Marche

Ancona, 60100, Italy

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age 5-10 -

Exclusion criteria

celiac disease, on a gluten free diet

-

Treatment and study plan

Primary outcomes

  1. prevalence of celiac serology in children aged 5-10

    Time frame: 2 years

Secondary outcomes

  1. prevalence of dental caries in children genetically predisposed to CD in comparison with children not predisposed

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Università Politecnica delle Marche

Other

Collaborators

  • Azienda ULSS di Verona e Provincia
  • FONDAZIONE CARIVERONA

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Apr 30, 2021
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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