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临床试验/NCT06926166
NCT06926166招募中不适用

Human Genes and Microbiota in Early Life (HuGME)

Guangzhou Women and Children's Medical Center1 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20,000
试验地点
1
主要终点
Numbers of participants with Childhood diseases. Including:

研究概览

简要总结

The long-term goal of the Human Genes and Microbiota in Early Life (HuGME) is to explore the short- and long-term effects of maternal microbiota during pregnancy and the microbiota colonization of their offspring early in life and their interaction with the host on maternal-offspring health consequences in later life in the born in Guangzhou cohort study in China. Identification of the effect of microbiota in early life, as well as environmental factors and microbe-host interaction, will lead to a better understanding of disease pathogenesis and provide a foundation for targeted mechanistic investigation into the consequences of microbial-host crosstalk for long-term health. It also can result in new strategies to predict and prevent diseases in later life.

详细描述

Prenatal and early postnatal life represent critical windows for growth and cognitive and immune system development. In addition to genetics and host biology, the environment plays a critical role in the health of a child. One key player in this process is the maternal and infant gut microbiomes. The establishment and progression of the intestinal microbiota from birth to childhood are dependent on a range of factors, including maternal microbiota, diet, environment, and medical exposures. The host-microbial crosstalk during this time is thought to be involved in the pathobiology of later-life diseases, such as allergic disease, obesity, and neurodevelopmental delay. Although the microbiome and its importance for health have been extensively studied, it remains unclear how maternal microbiota-fetal interaction, the establishment, and progression of microbiota in infant adaptation to postnatal environmental exposures, and microbial-host crosstalk affect the health of the children in later life.

Hypotheses:

  1. Maternal microbiota-fetal interaction has an essential effect on fetal immune system development and adverse pregnancy outcomes.
  2. Host genes can shape infant gut microbial assembly and metabolism.
  3. Early-life interactions between host genes and microbiota have an impact on immune system development and atopic disease in later life.
  4. Co-metabolism of the gut microbiome and metabolites in the host affects childhood obesity
  5. Early-life interactions between the host and microbiota have an impact on the neurodevelopment of the children.
  6. Maternal microbiota influence the metabolism of the mother during pregnancy and postpartum.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Pregnant women with < 20 weeks of gestation Pregnant women intended to eventually deliver in Guangzhou Women and Children's medical center Permanent residengts of families intended to remain in Guangzhou with their child for ≥3 years

排除标准

  • Refuses to have blood and stool samples stored at Born in Guangzhou cohort study Biobank.

研究组 & 干预措施

No treatment

No treatment

干预措施: No intervention (Other)

结局指标

主要结局

Numbers of participants with Childhood diseases. Including:

时间窗: 42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years of age

Obesity,asthma,allergic diseases,Delayed neural development,type 1 diabetes,maturity-onset diabetes of the young(MODY), hypertension

Numbers of participants with maternal diseases. Including:

时间窗: during pregnancy, 42 days, 6 months, 1, 3, 6, 8-9, 14, and18 years after delivery

Obesity,asthma,allergic diseases,type 1 diabetes,type 2 diabetes, hypertension , cardiovascular diseases,and obstetric complications,including gestational diabetes,pregnancy induced hypertension, ect.

次要结局

  • maternal and childhood abnormal glucose metabolism after delivery(3, 6 and 9 years after delivery)
  • maternal and childhood abnormal lipid metabolism after delivery(3, 6 and 9 years after delivery)
  • Neurodevelopment during preschool age(at age of 6 years)
  • Neurodevelopment during early childhood(at age of 3 years)
  • Neurodevelopment during preadolescence(at age of 8-9 years)

研究者

发起方
Guangzhou Women and Children's Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiu Qiu

The division of the born in Guangzhou cohort study

Guangzhou Women and Children's Medical Center

研究点 (1)

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