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临床试验/NCT03116568
NCT03116568进行中(未招募)不适用

A Prospective Study of Pregnant Women With and Without IBD in Order to Better Understand the Patterns of Bacterial Transmission From the Mother to the Baby (Bacterial Transmission In Utero and IBD Risk)

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2017年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
180
试验地点
1
主要终点
Relation of microbiota in the gut between mother and new-borns

研究概览

简要总结

Inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC), are caused by the loss of mucosal tolerance towards the commensal microbiota resulting in inflammatory responses.

Identifying intestinal bacteria in mother and newborn of both IBD and Control groups allow us to understand the change of bacterial composition human microbiome in the gut during pregnancy and childhood development.

详细描述

Inflammatory bowel diseases (IBD), Crohn's disease (CD) and ulcerative colitis (UC), are caused by the loss of mucosal tolerance towards the commensal microbiota resulting in inflammatory responses.

Human microbiome studies have demonstrated dynamic changes in bacterial composition in the gut during pregnancy and childhood development. Moreover, the presence of pathogenic species, or absence of beneficial species, in early childhood has been suggested to play a key role in the initiation of preterm birth, development of asthma or eczema, allergy, autism or other immunological deficiency. The goal of this study is to better understand the link between maternal and newborn microbiome. Specifically, we will investigate the microbial composition of the stool of newborn babies born to mothers with certain health issues as compared to healthy mothers. This information may help identify the factors that can help better understand the risk transmitted through the microbiome.

By collecting the samples including stools, saliva and understanding the health history of pregnant women with or without Inflammatory bowel disease (IBD), we can compare the data of two groups pregnant women in order to find out the differences of microbiome in their guts. Another aim of our study is finding out the possibility of vertical bacteria transmission from mother to baby.

Furthermore, our main focus is the meconium of newborn baby, we would like to know that the differences of microbiome in the gut between the newborns from two groups. Therefore, we will collect the umbilical cord blood, placenta, amniotic membrane, newborn cheek swab, and meconium. To investigate the disease transmission rate from mothers.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 100 Years(Child, Adult, Older Adult)
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

Relation of microbiota in the gut between mother and new-borns

时间窗: 5 years after the mother give birth

Identify different type of intestial bacteria between both IBD and Control groups

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siew Chien NG

Professor

Chinese University of Hong Kong

研究点 (1)

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