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Risk Factors for the Development of Celiac Disease in Genetically Predisposed Children

NCT04034303 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2019-08-02

No results posted yet for this study

Summary

The study aims to identify risk factors for the development of Celiac Diseases in families with a recognized genetic risk for the presence of a confirmed proband case. Candidate mother will be recruited before a planned pregnancy or within the first 12 weeks of pregnancy. Familial and environmental risk factors will be evaluated within the couple of parents. Pregnancy will be followed up and appropriate biological samples collected. Delivery will be supervised in order to collect biological samples. Newborns will be controlled from birth up to the 6th year of age. Data about clinical events related to health, life attitudes, nutrition will be collected together with biological samples either in the pregnant mother as well as in the infant.

Conditions

  • Prevention of Clinical Symptoms in Celiac Disease

Interventions

GENETIC

analysis of genetic and epigenetic risk factors

analysis of gene, methylation and expression, microbiome

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2022-05-01
Completion
2025-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04034303 on ClinicalTrials.gov