跳至主要内容
临床试验/NCT03396198
NCT03396198Unknown不适用

An Observational Study of Intestinal Flora in Infants

Mizu Jiang1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年12月22日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Intestinal Flora Sequencing

研究概览

简要总结

The purpose of this study is to investigate the influence factors of gastrointestinal microbiome in infants.

详细描述

The gastrointestinal microbiome is believed to be critically important for infant growth and development. As we all know, the gut microbiota can influence gut maturation, metabolic, immune and brain development in early life. Host genotype, gestational age, antibiotic use, mode of delivery, diet and the context in which the infant is born (rural vs urban, presence of siblings, pets and other factors) can influence the development of infant gut microbiota. In the early life stage, intestinal flora disorders may alter the host immune function and increase the susceptibility to immune or metabolic diseases.

This research intends to establish a birth cohort of healthy newborns. The influence factors of gastrointestinal microbiome will be investigated by means of questionnaire survey, specimen collection and high throughput sequencing analysis. What's more, the correlation of gut microbiome, infant growth as well as related diseases will be explored either. The results will provide constructive suggestions for the establishment of infant normal intestinal flora and play an indispensable role in exploring the occurrence, development and prevention of related diseases.

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 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy newborns

排除标准

  • Newborns with diseases such as congenital heart disease or congenital malformation and so on

结局指标

主要结局

Intestinal Flora Sequencing

时间窗: Intestinal Flora Sequencing Change from Baseline to 12 months after Birth

Intestinal Flora Sequencing

次要结局

未报告次要终点

研究者

发起方
Mizu Jiang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mizu Jiang

Director of Gastroenterology Laboratory of the Affiliated Children's Hospital of Zhejiang University Medical School

Zhejiang University

研究点 (1)

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