NCT00724204已完成1 期
Functional Evaluation of a Follow on Formula Supplemented With Lactobacillus Salivarius CECT5713
Puleva Biotech2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2006年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Adverse reactions
研究概览
简要总结
The aim of the trial is to evaluate safety of a follow on formula supplemented with Lactobacillus salivarius CECT5713. A randomized double blind placebo controlled trial was carried out. Eighty six months old children were recruited by the department of pediatrics of Hospital Univeristario San Cecilio. Children were divided in two groups that consumed a follow on formula supplemented or not with the probiotic strain during 6 months. Fecal samples were obtained at the recruitment, at 3 months and at the end of the trial. In addition revision by the pediatrician was performed once a month and possible adverse effects were recorded both by the pediatrician and by parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy six months old children
排除标准
- •Lactose intolerance
- •Cow's milk protein allergy
- •Serious metabolic diseases
- •Antibiotic treatment
- •Serious gastrointestinal diseases
结局指标
主要结局
Adverse reactions
时间窗: 3 months and 6 months
次要结局
- growth parameters (height, length, head circumference)(3 months and 6 months)
- Fecal microbiota(3 months and 6 months)
- Fecal short chain fatty acids(3 months and 6 months)
研究者
研究点 (2)
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