Finnish Health and Early Life Microbiota (HELMi) Longitudinal Birth Cohort
试验速览
- 阶段
- 不适用
- 入组人数
- 1,055
- 试验地点
- 1
- 主要终点
- Longitudinal change of intestinal microbiota in early life
研究概览
简要总结
The aim of this cohort is to identify environmental, lifestyle and genetic factors that modify the human intestinal microbiota development during the first years of life, and to identify early microbiota features that associate to child health and well-being with focus on the development of allergic diseases and overweight.
详细描述
1055 healthy term infants born in 2016-2018 mainly at the capital region of Finland, and their parents. Fecal samples collected from infants and their parents. Electronic questionnaires on a weekly basis during the first 4 months of life, thereafter less frequently. Focus on diet, well-being and health and social manners. At one-year and at two-years comprehensive questionnaires including development and cognition. Parental stress evaluation included.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General population, singleton pregnancy, at least one parent Finnish speaking
- •Willingness and ability of parents to consent for 2 year follow-up involving frequent electronic questionnaires and freezing of faecal samples at home
- •Infant born on gestational weeks 37-42 without known congenital defects
- •Exclusion Criteria
- •Preterm birth
- •Severe birth defect
- •Parents fail to activate the online questionnaires
排除标准
- 未提供
结局指标
主要结局
Longitudinal change of intestinal microbiota in early life
时间窗: From 3 weeks to 2 years after birth
Developmental trajectory of the intestinal microbiota, assessed with 16S rRNA gene amplicon and shotgun sequencing of fecal DNA to determine the changes in the intestinal microbiota composition, diversity and functionality from week 3 to weeks 6,9,12 and months 6,9,12,18 and 24 after birth.
次要结局
- Weight(At 6,12,18 and 24 months after birth)
- Number of children with asthma(At 2 years)
- Number of children with allergic disease(At 2 years)
- Child development(At 18 and 24 months after birth)
- Number of respiratory tract infection episodes(From birth to 2 years of age)
- Growth(At 6,12,18 and 24 months after birth)
研究者
Anne Salonen
Principal Investigator
University of Helsinki