跳至主要内容
临床试验/NCT05597904
NCT05597904招募中不适用

Genetic and Biological Background and Follow-up of Different Phenotypes of Coeliac Disease

Tampere University Hospital1 个研究点 分布在 1 个国家目标入组 3,500 人开始时间: 2022年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,500
试验地点
1
主要终点
Non-HLA variant association

研究概览

简要总结

The main purpose of this study is to investigate genetic, serological, immunological and microbiata diversities between different coeliac disease phenotypes and to discover applicable prognostic markers for specific phenotypes.

详细描述

The recognition of clinical heterogeneity has expanded the understanding of coeliac disease, but the factors contributing to this diversity remain unclear. Moreover, since coeliac disease is highly heterogeneous, there is a need for more individualized follow-up and support and implementation of more personalized follow-up guidelines.

In this study coeliac disease and dermatitis herpetiformis patients and healthy controls will be recruited. Genetic, clinical, immunological, micobiata and novel biomedical markers are compared between coeliac disease phenotypes and also controls and their prognostic value is assessed.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis
  • Cohort 3: friend or non-related family member of coeliac disease or dermatitis herpetiformis patient

排除标准

  • Cohorts 1-3: Age <18 years
  • Cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis not confirmed
  • Cohort 3: coeliac disease or dermatitis herpetiformis diagnosis

结局指标

主要结局

Non-HLA variant association

时间窗: baseline

phenotype specific non-HLA variants

次要结局

  • microbiata(baseline)
  • serum transglutaminase antibodies(baseline)
  • quality of life measure(baseline)
  • gastrointestinal symptoms(baseline)
  • dietary adherence(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Teea Salmi

Professor in Dermatology

Tampere University Hospital

研究点 (1)

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