NCT04867863

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,570

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

April 27, 2021

Last Update Submit

April 27, 2021

Conditions

Celiac DiseaseDental Caries

Keywords

celiac diseasechildrencariesHLA DQ2HLA DQ8screening

Outcome Measures

Primary Outcomes (1)

  • prevalence of celiac serology in children aged 5-10

    2 years

Secondary Outcomes (1)

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

    2 years

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children aged 5-10 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics Universita' Politecnica Delle Marche

Ancona, 60100, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Celiac DiseaseDental Caries

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesTooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR OF PEDIATRICS AND HEAD OF THE DEPARTMENT OF PEDIATRICS, UNIVERSITA POLITECNICA DELLE MARCHE

Study Record Dates

First Submitted

April 27, 2021

First Posted

April 30, 2021

Study Start

May 1, 2015

Primary Completion

February 1, 2016

Study Completion

June 1, 2018

Last Updated

April 30, 2021

Record last verified: 2021-04

Locations

IT(1)