SCREENING OF CELIAC DISEASE IN SCHOLAR CHILDREN IN ITALY | NCT04867863

Studies
SCREENING OF CELIAC DISEASE IN SCHOLAR CHILDREN IN ITALY

NCT04867863

Sponsor

Università Politecnica delle Marche

Status

Completed

Last Update Posted

Apr 30, 2021Actual

Enrollment

4,570Actual

Phase

Not provided

Conditions

Celiac Disease
Dental Caries

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Jun 2018Actual

First Submitted Date

Apr 27, 2021

First Submission Date that Met QC Criteria

Apr 27, 2021

First Posted Date

Apr 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2021

Last Update Posted Date

Apr 30, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carlo Catassi, M.D., PROFESSOR OF PEDIATRICS AND HEAD OF THE DEPARTMENT OF PEDIATRICS, UNIVERSITA POLITECNICA DELLE MARCHE, Università Politecnica delle MarchePrincipal Investigator

Lead Sponsor

Università Politecnica delle MarcheOTHER

Collaborators

Name	Class
FONDAZIONE CARIVERONA	UNKNOWN
Azienda ULSS di Verona e Provincia	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

4,570Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: age 5-10 -

Exclusion Criteria: celiac disease, on a gluten free diet

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Children aged 5-10 years

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics Universita' Politecnica Delle Marche		Ancona		60100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D002446	Celiac Disease
D003731	Dental Caries

Ancestor Terms

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided