NCT01625273已完成不适用
Supplementation of Infant Formula With the Synbiotics (Lactobacillus Paracasei Ssp. Paracasei Strain F19 and Fructo- and Galactooligosaccharides).
Arla Foods2 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2010年1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
- 182
- 试验地点
- 2
- 主要终点
- Growth (body weight, length, head circumference)
研究概览
简要总结
The primary hypothesis is that Lactobacillus paracasei ssp. paracasei strain F19 in an infant formula containing FOS/GOS is safe and tolerable for use in infants from 0 to 6 months.
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
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy infants of mothers who voluntarily resigned completely from breastfeeding
- •infant age 28 days
- •delivered between 38 and 42 weeks of gestation
- •vaginal delivery
- •birth weight > 2700 g and < 4200 g
- •parent or the subject's legal representative has to speak and understand Polish
排除标准
- •fully or partially breastfed infants
- •malformations, handicaps or congenital diseases that could affect normal growth
- •treatment with antibiotics
- •fed infant formula with pre- and/or probiotics
结局指标
主要结局
Growth (body weight, length, head circumference)
时间窗: From 28 days to 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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