A Follow-up Clinical Study to Investigate the Long Term Effect of Supplementation of Pre- and Probiotics in Early Life in Children Born by Caesarean Section (Julius SN Follow-up 1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Incidence of gastrointestinal symptoms
研究概览
简要总结
This study investigate the long term effect of supplementation of pre- and probiotics in early life in children born by Caesarean Section.
详细描述
This is an extension of investigation on the long term effect of supplementation of pre- and probiotics in early life in children born by Caesarean Section from an earlier completed study.
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
- 36 Months 至 54 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participation in the Julius SN study until 16 weeks of age
- •Written informed consent from parent(s) or legally acceptable representatives
排除标准
- •Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements.
结局指标
主要结局
Incidence of gastrointestinal symptoms
时间窗: 3 - 4 years old
Difference in parent-reported cumulative incidences of gastrointestinal symptoms between study groups
Absolute count of Bifidobacterium
时间窗: 3 - 4 years old
Difference in absolute count of bifidobacterium between study groups
Absolute level of fecal lactate
时间窗: 3 - 4 years old
Difference in absolute level of fecal lactate between study groups
Incidence of allergy manifestation
时间窗: 3 - 4 years old
Difference in parent-reported cumulative incidences of allergy manifestation between study groups
Incidence of infection
时间窗: 3 - 4 years old
Difference in parent-reported cumulative incidences of infection between study groups
次要结局
未报告次要终点