NCT01755481已完成不适用
Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate
Arla Foods1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2012年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Infections episodes (gastrointestinal and upper and lower respiratory infections)
研究概览
简要总结
To evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei strain F19 or Whey Protein Concentrate.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(formula-fed group):
- •healthy infants of mothers who could not or voluntarily resigned completely from breast-feeding at infant age 14 plus/minus 3 days
- •Inclusion criteria (breast-fed group):
- •healthy infants exclusively breast-fed from birth and mothers intending to breastfeed >80% until at least 5th month of age (meaning through the 4th month of age).
- •Inclusion criteria (all infants):
- •delivered between 37 and 42 weeks of gestation birth weight >2500 g and <4000 g parent or the subject's legal representative speak and understand Chinese
排除标准
- •(formula-fed group):
- •fully or partially breast-fed infants infants breast-fed >20%
- •Exclusion criteria (breast-fed group):
- •infants fed >20% infant formula
- •Exclusion criteria (all infants):
- •malformations, handicaps or congenital diseases that could affect normal feeding or growth treatment with antibiotics
研究组 & 干预措施
Probiotics F19
Experimental
F19 in an infant formula
干预措施: Probiotic (Other)
Whey protein concentrate
Experimental
Whey protein concentrate in an infant formula
干预措施: Whey protein concentrate (Other)
结局指标
主要结局
Infections episodes (gastrointestinal and upper and lower respiratory infections)
时间窗: 4 yrs
次要结局
未报告次要终点
研究者
研究点 (1)
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