Celiac DiseaseNCT04867863
SCREENING OF CELIAC DISEASE IN SCHOLAR CHILDREN IN ITALY
An observational study of Celiac Disease and Dental Caries, run by Università Politecnica delle Marche at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Celiac Disease, Dental Caries
- How many people
- 4,570 participants
- Where
- 1 siteItaly
- Study dates
- May 2015to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 5-10 years
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Pediatrics Universita' Politecnica Delle Marche
Ancona, 60100
About this study
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).
Read the 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)
- Conditions
- Celiac Disease, Dental Caries
- Keywords
- celiac disease, children, caries, HLA DQ2, HLA DQ8, screening
- Medical subject headings
- Celiac Disease, Dental Caries
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of celiac serology in children aged 5-10
Measured: 2 years
Secondary outcomes (1)
prevalence of dental caries in children genetically predisposed to CD in comparison with children not predisposed
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study startMay 2015
- Primary completionFeb 2016
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 4,570 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Collaborators
- FONDAZIONE CARIVERONA, Azienda ULSS di Verona e Provincia
- Responsible party
- Principal investigator, Carlo Catassi, M.D., Università Politecnica delle Marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867863
- Sponsor's protocol ID
- 121CELIA14
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCREENING OF CELIAC DISEASE IN SCHOLAR CHILDREN IN ITALY
- ClinicalTrials.gov ID
- NCT04867863
- Acronym / sponsor ID
- 121CELIA14
- Conditions
- Celiac Disease, Dental Caries
- Keywords
- celiac disease, children, caries, HLA DQ2, HLA DQ8, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,570 participants (actual)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Collaborators
- FONDAZIONE CARIVERONA, Azienda ULSS di Verona e Provincia
- Study start
- May 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 5-10 years
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of celiac serology in children aged 5-10
Time frame: 2 years
1 secondary outcome
prevalence of dental caries in children genetically predisposed to CD in comparison with children not predisposed
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease and Dental Caries, run by Università Politecnica delle Marche at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of celiac serology in children aged 5-10 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.