Esophageal Atresia: a Natural Experiment of the Effects of Oral Inoculation on the Gut Microbiome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in Gut Microbial Community Structure
研究概览
简要总结
The purpose of this study is to understand changes of the gut microbiome due to esophageal atresia. The intervention will be to give a patient his or her own saliva through their gastrostomy tube (directly into the stomach) to observe if this can normalize microbial colonization of the gut.
详细描述
After being informed about the study and its overall risks, parents will be given the option to enroll their infant. Participants (infants) with esophageal atresia and a gastrostomy tube will be given their own saliva through their gastrostomy tube, directly into the stomach. Samples of saliva and stool will be collected from these infants, and from a comparison group without esophageal atresia, as well as blood and urine to look for changes in immune responses and in metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates with Esophageal Atresia (All, no exclusion criteria); maximum age at enrollment is 3 months.
- •Neonates matched for gestational age without EA, also anticipated to require surgery (Infants >=32 weeks), or also premature (<32 weeks)
- •Exclusion Criteria (only for infants without EA):
- •admission to study hospital after 7 days old
- •expected length of stay <2 weeks
排除标准
- 未提供
结局指标
主要结局
Change in Gut Microbial Community Structure
时间窗: From birth until discharge from the hospital, up to 1 year
Evaluate community structure and differential abundances of dominant taxa and of key taxa to the newborn (e.g., Bifidobacterium, Bacteroides, Lactobacillus, Staphylococcus and Enterobacteriaceae)
次要结局
- Change in Fecal Metabolome Profile(From birth until discharge from the hospital, up to 1 year)
- Change in Immune System Profile(From birth until discharge from the hospital, up to 1 year)
- Change in Blood Metabolome Profile(From birth until discharge from the hospital, up to 1 year)
研究者
David A. Relman
Professor, Medicine - Infectious Disease
Stanford University