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NCT04867863 Clinical Trial

SCREENING OF CELIAC DISEASE IN SCHOLAR CHILDREN IN ITALY

Dental Caries Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04867863
Other study ID # 121CELIA14
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2015
Est. completion date June 2018

Study information
Verified date April 2021
Source Università Politecnica delle Marche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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)

Recruitment information / eligibility
Status Completed
Enrollment 4570
Est. completion date June 2018
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender All
Age group 5 Years to 10 Years
Eligibility Inclusion Criteria: age 5-10 - Exclusion Criteria: celiac disease, on a gluten free diet -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Department of Pediatrics Universita' Politecnica Delle Marche Ancona

Sponsors (3)
Lead Sponsor Collaborator
Università Politecnica delle Marche Azienda ULSS di Verona e Provincia, FONDAZIONE CARIVERONA

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary prevalence of celiac serology in children aged 5-10 2 years
Secondary prevalence of dental caries in children genetically predisposed to CD in comparison with children not predisposed 2 years
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