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临床试验/NCT03001167
NCT03001167已完成不适用

Early Life Antibiotics, Gut Microbiome Development, and Risk of Childhood Obesity

Children's Hospital of Philadelphia1 个研究点 分布在 1 个国家目标入组 509 人开始时间: 2016年12月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
509
试验地点
1
主要终点
cumulative microbial diversity

研究概览

简要总结

This cross-disciplinary study will assemble and longitudinally follow a large, diverse birth cohort to determine the relationships between early life antibiotic exposure, microbiome development, growth, antibodies, and immunostimulation.

详细描述

Perinatal and infant antibiotic exposures are common and have been linked to changes in the gut microbiome, which plays a central role in health and disease. Childhood obesity is an epidemic and animal models have linked antibiotic induced changes in the microbiome with increased adiposity. Infants become colonized with trillions of bacteria in the first few hours of life. During this time period, their nascent immune system develops tolerance to commensal microbes

The primary objectives are to measure the impact of common perinatal and early childhood antibiotic exposures on the structure and function of the developing gut microbiome. To determine the association between common perinatal and early childhood antibiotic exposures and weight/adiposity gain in a large birth cohort of children. To determine mechanisms for the association between microbiome changes over time and the rate of weight/adiposity gain in a large birth cohort of children. To determine the normal developmental pattern by which healthy children develop antibodies in their blood against the microbes that naturally colonize their intestines. To determine the association between immunostimulation and protection from persistent colonization in humans.

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
— 至 96 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

cumulative microbial diversity

时间窗: 24 months

weight trajectory adjusted for time varying length

时间窗: 24 months

次要结局

  • fat stores in the upper arm/extremity(24 months)
  • Use autologous serum antibodies to "tag" fecal microbes(24 months)
  • fat stores in the upper back/trunk(24 months)
  • total number of individual bacterial taxa(24 months)
  • supine length trajectory(24 months)
  • expression levels of bacterial gene categories(24 months)
  • determine the association between immunostimulation and protection from persistent colonization in humans(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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