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临床试验/NCT00948051
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

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

发起方
Syral
申办方类型
Industry

研究点 (1)

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