NCT01215656已完成2 期
Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections
Puleva Biotech0 个研究点目标入组 188 人开始时间: 2008年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 188
- 主要终点
- Incidence of infectious diseases
研究概览
简要总结
The objective of the study is to evaluate the effects of a follow on formula containing the human milk probiotic Lactobacillus fermentum on the incidence of infection in 6 months old infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 6 Months 至 7 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6 months old children born at term
- •written consent from parents
排除标准
- •frequent gastrointestinal disorders (frequent diarrhoeas, constipation episodes, gastroesophageal reflux)
- •gastrointestinal surgery
- •cow's milk protein allergy
- •metabolic diseases (diabetes or lactose intolerance)
- •immune deficiency
- •antibiotic treatment during the trial and/or recent (within the preceding 3 weeks)
结局指标
主要结局
Incidence of infectious diseases
次要结局
未报告次要终点
研究者
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