SCREENING OF CELIAC DISEASE IN SCHOLAR CHILDREN IN ITALY

Completed

• Conditions: Celiac Disease; Dental Caries

• Registration Number: NCT04867863
• Lead Sponsor: Università Politecnica delle Marche

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).

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 Timeline

• Study Start: 2015-05
• Primary Completion: 2016-02
• Study Completion: 2018-06
• Status Verified: 2021-04
• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-27
• Last Update Submitted: 2021-04-27
• Study First Posted: 2021-04-30
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4570

Inclusion Criteria

age 5-10 -

Exclusion Criteria

celiac disease, on a gluten free diet

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of celiac serology in children aged 5-10	2 years

Secondary Outcome Measures

Name	Time	Method
prevalence of dental caries in children genetically predisposed to CD in comparison with children not predisposed	2 years

Trial Locations

Locations (1)

Department of Pediatrics Universita' Politecnica Delle Marche; 🇮🇹 Ancona, Italy