SCREENING OF CELIAC DISEASE IN SCHOLAR CHILDREN IN ITALY

April 27, 2021 updated by: Carlo Catassi, M.D., Università Politecnica delle Marche
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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

4570

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy, 60100
        • Department of Pediatrics Universita' Politecnica Delle Marche

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children aged 5-10 years

Description

Inclusion Criteria: age 5-10 -

Exclusion Criteria: celiac disease, on a gluten free diet

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevalence of celiac serology in children aged 5-10
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
prevalence of dental caries in children genetically predisposed to CD in comparison with children not predisposed
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Politecnica delle Marche

Collaborators

FONDAZIONE CARIVERONA
Azienda ULSS di Verona e Provincia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 121CELIA14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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