NCT01992497已完成不适用
Effect,Tolerance and Safety of a Supplementation With a Probiotic in Healthy Newborn Term Infants Born by Cesarean Section Over a 12 Months Period Study
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 721 人开始时间: 2013年12月1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
- 721
- 试验地点
- 2
- 主要终点
- Number of diarrhea episodes between a probiotic vs. placebo
研究概览
简要总结
Effect, tolerance and safety of a supplementation with a probiotic on the risk of gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants born by Cesarean section. Exploratory comparison between a probiotic vs. placebo in the formula-fed and in the breastfed feeding groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Minute 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written informed consent must be obtained from legal guardian(s) prior to randomization or any study related procedures
- •healthy newborns
- •born by Cesarean section
- •singleton birth
- •Age at enrollment in the study < 24h
- •birth weight ≥ 2500g and ≤ 4300g
- •gestational age ≥ 37 weeks and ≤ 42 weeks
排除标准
- •congenital diseases or malformations that may inhibit growth
- •prenatal and/or postnatal diseases
- •parents are expected to have difficulty complying with the feeding regime
- •planned re-admittance to the hospital in the first 14 days of life
- •antibiotic treatment at the time of enrollment in the study
结局指标
主要结局
Number of diarrhea episodes between a probiotic vs. placebo
时间窗: 12 months
次要结局
- Diarrhea duration between a probiotic vs. placebo(12 months)
研究者
研究点 (2)
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