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临床试验/NCT00823056
NCT00823056已完成3 期

The Effect of Probiotics on Infections in Toddlers

Zealand University Hospital2 个研究点 分布在 1 个国家目标入组 454 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
454
试验地点
2
主要终点
fewer infections

研究概览

简要总结

Probiotics has been known as a dietary supplement for a long period. Recent clinical trials indicate that probiotics might have an effect in preventing common infection diseases in children.

The investigators hypothesis is: if young children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.

详细描述

Probiotics has been known as a dietary supplement for a long period. Recent clinical trials indicate that probiotics might have an effect in preventing common infection diseases in children.

Our hypothesis is: if young healthy children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics( BB12 and TH4) in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.

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 (Participant, Investigator)

入排标准

年龄范围
6 Months 至 7 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy Children born in University Hospital Holbaek,Hospital North,Region Zealand, Denmark in the period of Jan. 2009 to Oct. 2010
  • Gestational age >

排除标准

  • Chronical heart or lung conditions
  • Short Bowel Syndrome
  • CVC (Central Venous Catheter)

结局指标

主要结局

fewer infections

时间窗: 9 months

次要结局

  • growth(9 months)

研究者

申办方类型
Other

研究点 (2)

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