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临床试验/NCT02654210
NCT02654210进行中(未招募)不适用

LoewenKIDS - Infections and the Development of the Immune System

Helmholtz Centre for Infection Research2 个研究点 分布在 1 个国家目标入组 782 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
782
试验地点
2
主要终点
Development of immune system

研究概览

简要总结

The purpose of this study is to determine in what way infections, microbiome, and vaccinations during childhood interact in shaping the development of immunity and tolerance. The investigators collect and use data from a birth cohort focusing on infectious diseases during childhood and apply a life course perspective.

详细描述

The goal of the study is to capture the complete history of exposure towards microbial challenges in the first six years of life and to study interactions between different components of microbial exposure as well as effects on the development of immunity. The investigators apply a diary in which parents document symptoms of respiratory and gastrointestinal infections of their child, and collect nasal swabs and stool samples obtained on first day of symptoms. In addition, the investigators collect nasal swabs and stool samples once per year during an asymptomatic period. The investigators intend to collect venous blood from children participating in the study at the age of six years. In a subsample (called intensive subcohort), the investigators collect asymptomatic probes three monthly during the first two years of life and obtain venous blood of the children at the age of one and two years.

The study sample is 782 participants, with 285 participants in the intensive subcohort.

Symptomatic samples will be analyzed by means of multiplex polymerase chain reaction (PCR). In addition, the investigators will assess microbial compositions based on next generation sequencing and apply multiplex panels to study parameters of unspecific humoral immune response. The study will allow to assess homologous and heterologous effects of infections and vaccinations measuring specific humoral immune response. In collaboration with immunologists, immune phenotypes will be studied and functional tests will be conducted.

The investigators will use allergic dermatitis at the age of two as a primary proxy outcome and target asthma at the age of six years as a definitive clinical endpoint.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • newborn in a study region

排除标准

  • parents < 18 years old
  • insufficient knowledge of the German language (parents)

结局指标

主要结局

Development of immune system

时间窗: 15 years

Assessment of interactions between infections, microbial colonization, vaccinations and immune response in the framework of life-course epidemiology

次要结局

  • Asthma(at age of six years)
  • Allergic dermatitis (yes/no)(at age of two years)

研究者

发起方
Helmholtz Centre for Infection Research
申办方类型
Other
责任方
Sponsor

研究点 (2)

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