NCT00948051已完成不适用
A Placebo-controlled, Double-blind Randomized Study to Evaluate the Efficacy of a follow-on Milk Formula Supplemented With Fructo-oligosaccharides on Immune Response in Healthy Infants
Syral1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年3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
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's response to vaccination
研究概览
简要总结
In this study the investigators hypothesized that the chronic intake of fructo-oligosaccharides would increase fecal immunoglobulin A (IgA) specific to poliovirus vaccination and bifidobacteria in infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Months 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •infants aged of 4 months at randomization
- •not breast-fed infants
排除标准
- •infants suffering from a chronic or severe disease susceptible to interfere with one of the evaluation criteria
- •infants suffering from a disease associated with gastro-intestinal disorder
- •infants who have taken antibiotic during the 2 months preceding randomization
结局指标
主要结局
To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's response to vaccination
时间窗: 1 month
次要结局
- To evaluate the impact of the intake of a follow-on milk formula supplemented with FOS in increasing infant's faecal bifidobacteria concentration(1 month)
研究者
研究点 (1)
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