Potential Restoration of the Infant Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Bacterial diversity of several body sites on mother and baby throughout one year post-birth as measured by the number and type of different bacteria present
研究概览
简要总结
Understanding the microbiome's important role in human health, the investigators wish to determine how the development of the infant microbiome is impacted by delivery mode, comparing natural vaginal birth to scheduled C-sections. Investigators will look at the oral, nasal, skin, vaginal and fecal bacteria of 78 mothers and their infants from birth to age 1.
详细描述
Human microbiota play an important role in the functioning of various organs, as well as the education of the immune system. Mammals have evolved to be born non-sterile, covered with the maternal vaginal bacteria that populate the maternal birth canal, as well as to exclusively breastfeed during early development. Unfortunately, these processes are substantially altered with modern Western practices, which may have health consequences. In particular, C-section is associated with an increased risk of immune diseases and allergies. This study explores the effects of exposing neonates to the vaginal environment at birth, perinatal antibiotics, and lactation on the acquisition of new microbial genes during the first year of infant microbiome development.
This study follows 78 babies from healthy mothers (18-40 years old) with uncomplicated pregnancies. The babies are divided into three groups according to their exposure to the vaginal environment at birth:
Group 1: (n-26) Babies born via vaginal delivery.
Group 2: (n-26) Babies born via scheduled C-section without exposure to mother's vaginal bacteria just after birth.
Group 3: (n-26) Babies born via scheduled C-section with exposure to mother's vaginal microbiota just after birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vaginal Delivery
Babies that are born via vaginal delivery, either at home, at a birthing center or hospital. Drugs may be administered during labor.
Scheduled C-section
Babies that are scheduled to be born in a hospital via standard C-section procedure.
Scheduled C-section with Exposure
Babies that are scheduled to be born in a hospital via standard C-section procedure, as well as are swabbed with gauze containing their mother's vaginal microbiota just after delivery. The intervention: Newborn exposure to mother vaginal microbiota.
干预措施: Newborn exposure to mother vaginal microbiota (Other)
结局指标
主要结局
Bacterial diversity of several body sites on mother and baby throughout one year post-birth as measured by the number and type of different bacteria present
时间窗: Day of Birth; Days 1 and 3; Weeks 1, 2, 3 and 4; Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11; Year 1
Investigators will first use Illumina to obtain sequences of the bacterial mitochondrial DNA from collected samples. QIIME, LEfSe, and other bioinformatic tools will then be used to calculate the bacterial diversity (richness, relative abundances) in each sample, as well as compare bacterial communities (beta diversity), sourcetracking to determine origin from maternal sites, random forest to classify communities, and other tools to describe the dynamics of the infant microbiome.
次要结局
未报告次要终点