Impact of Probiotics Supplement on the Gut Microbiota in Caesarean-born Infants: an Open-label Single-center Randomized Parallel Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in gut microbiota at 14 days between no intervention and experimental group.
研究概览
简要总结
The purpose of this study is to evaluate the effect of probiotics on the gut microbiota of infants born by cesarean section.
详细描述
This study aims to examine the impact of probiotics administration on the gut microbiota of infants born by cesarean section. Birth,14 days and 42 days data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the infants born by cesarean section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Hour 至 42 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neonates born by caesarean section
排除标准
- •Gestational weeks <37 Birth weight <2500g or ≥4000g History of asphyxia anoxia at birth With congenital metabolic diseases or hereditary diseases With gastrointestinal diseases With infectious diseases
结局指标
主要结局
Change in gut microbiota at 14 days between no intervention and experimental group.
时间窗: 14 days
Study the microbiota change of stool samples 14 days between no intervention group and experimental group.
Change in gut microbiota at 42 days between no intervention group and experimental group.
时间窗: 42 days
Study the microbiota change of stool samples at 42 days between no intervention group and experimental group.
次要结局
- Change in gut microbiota at birth between no intervention and experimental group.(birth)
研究者
Huanlong Qin
Director
Shanghai 10th People's Hospital