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临床试验/NCT04140747
NCT04140747已完成不适用

Transfer of Strictly Anaerobe Microbes From Mother to Child - a Pilot Study

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2016年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
94
试验地点
1
主要终点
fetal/neonatal microbiome

研究概览

简要总结

This study aims to investigate the changes in the microbiota at different body sites in late pregnancy, in comparison with non-pregnant women, with particular emphasis on archaea, and to identify possible maternal-to-child transfer routes for acquisition of strictly anaerobic microorganisms by analyzing the gut microbiota of new born infants (delivered vaginally or by C-section).

详细描述

The investigators hypothesize that changes occur in the microbial community during pregnancy in different body sites (vagina, oral etc.) and that the main source of these microorganisms is the mother for vaginally born infants, while C-section born infants acquire most of the anaerobic microbial communities from other sources rather than mother's vaginal and gut microbiota, such as the environment.

Specific Research Objectives will be:

  1. To investigate diversity of archaea in the vagina of healthy women in the context with community state types (CSTs), and compare vaginal microbiome in pregnant with non-pregnant healthy women.
  2. To identify the presence of archaea in different body sites (oral, gut) or body fluids (amniotic fluid, urine, human milk) within the perinatal microbial communities.
  3. To investigate the presence of archaea in the infant's first-days-of-life intestinal community, and to identify the sources of these microorganisms by using source tracking approach.
  4. To investigate Human Milk Oligosaccharides (HMOs) in maternal (serum, saliva, urine, breast milk) or intrauterine sources (amniotic fluid) as potential modifiers of the microbial communities in these sites.
  5. To analyze associations of maternal/ intrauterine HMOs with infant HMOs and microbiota (meconium and infant stool) in order to investigate vertical transmission of microbiota to the infant.

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
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • healthy women
  • pregnant women: delivery at term (gestational age 37-42); contractions or rupture of membrane no longer than 12h before admission to hospital

排除标准

  • bacterial/ fungal infections
  • use of antibiotics/ probiotics in past 3 months
  • fetal anomalies
  • multiple pregnancies
  • diabetes type 1, 2, gestational diabetes
  • hypertension, preeclampsia/HELLP
  • HIV ( human immunodeficiency virus), HCV (Hepatitis C)
  • drug abuse, smoking

结局指标

主要结局

fetal/neonatal microbiome

时间窗: 2020-2023

difference between vaginal and C-section born infants

maternal microbiome

时间窗: 2020-2023

difference between non-pregnant and pregnant women

次要结局

  • Human milk oligosaccharides(2020-2023)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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