NCT01346644已完成不适用
Study of Tolerance of an Infant Formula Supplemented With Lactobacillus Fermentum CECT5716
Puleva Biotech2 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2009年2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
- 137
- 试验地点
- 2
- 主要终点
- average weight gain
研究概览
简要总结
In the last years manipulation of intestinal microbiota with probiotics has gained an increasing interest, specially in infant nutrition since recent studies has demonstrated the presence of probiotics in human milk. However, there are few studies studying the effects of probiotics in newborns. The objective of the present study is to analyze safety and tolerance of the probiotic Lactobacillus fermentum CECT5716 isolated from human milk.
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
- 21 Days 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy 1 month infants exclusively formula-fed
排除标准
- •gastrointestinal disorders (history of chronic diarrhoea or constipation, gastroesophageal reflux)
- •gastrointestinal surgery
- •cow's milk protein allergy
- •metabolic disorders (diabetes, lactose intolerance)
- •immune deficiency
- •antibiotic prescription 1-week prior to inclusion and previous use of formula containing prebiotics or probiotics
结局指标
主要结局
average weight gain
时间窗: 4 months
次要结局
- growth and health of infants(2,4,6,12 and 36 months of life)
研究者
研究点 (2)
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