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临床试验/NCT04867863
NCT04867863已完成不适用

SCREENING OF CELIAC DISEASE IN SCHOLAR CHILDREN IN ITALY

Università Politecnica delle Marche1 个研究点 分布在 1 个国家目标入组 4,570 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4,570
试验地点
1
主要终点
prevalence of celiac serology in children aged 5-10

研究概览

简要总结

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).

详细描述

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)

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • celiac disease, on a gluten free diet

结局指标

主要结局

prevalence of celiac serology in children aged 5-10

时间窗: 2 years

次要结局

  • prevalence of dental caries in children genetically predisposed to CD in comparison with children not predisposed(2 years)

研究者

发起方
Università Politecnica delle Marche
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Catassi, M.D.

PROFESSOR OF PEDIATRICS AND HEAD OF THE DEPARTMENT OF PEDIATRICS, UNIVERSITA POLITECNICA DELLE MARCHE

Università Politecnica delle Marche

研究点 (1)

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