NCT01715246已完成不适用
Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)
Société des Produits Nestlé (SPN)4 个研究点 分布在 2 个国家目标入组 176 人开始时间: 2012年10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
- 176
- 试验地点
- 4
- 主要终点
- Growth
研究概览
简要总结
The primary objective of this clinical study is to show that infants fed a standard starter infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants fed a standard starter infant formula without HMOs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- — 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy babies
- •Full term babies (37 weeks ≤ gestation ≤ 42 weeks)
- •birth weight between 2500 g- 4500g
- •Having obtained the baby's legal representative's informed consent.
- •FF groups:
- •babies aged between birth and 14 days, exclusively formula-fed at time of enrollment, whose mother independently elected, before enrollment, not to breastfeed
- •BF group: babies aged 3 months (+/- 5 days), exclusively breastfed since birth.
排除标准
- •Congenital illness or malformation that may affect growth
- •Significant pre-natal and/or serious post-natal disease before enrollment (by medical decision)
- •Minor parent(s)
- •Newborn whose parents / caregivers cannot be expected to comply with study procedures
- •Currently participating or having participated in another clinical trial since birth, except for BF group, where vaccines studies are allowed.
结局指标
主要结局
Growth
时间窗: 4 months of life
child growth (body weight) from enrollment to 4 months of age
次要结局
- Growth(6 and 12 months of age)
- Digestive tolerance (stool charecteristics, bowel movements,behavior patterns)(every month during 6 months)
- Stool microbiota(3 and 12 months of age)
- Gene expression(3 and 12 months of age)
- Product compliance (quantity of formula in ml consumed on the 3 days before visit)(every month for 6 months)
- Morbidity(ongoing for 1 year)
研究者
研究点 (4)
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