NCT01497314已完成不适用
An Open Label Clinical Study to Evaluate Growth and Safety of a Low Lactose Milk-Based Infant Formula in Healthy Term Infants
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 6
- 主要终点
- Weight
研究概览
简要总结
The purpose of this study is to show that a low lactose milk-based infant formula supports normal growth in healthy term infants.
详细描述
Infants will be fed a low lactose milk-based formula for 16 weeks. Growth and formula tolerability will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
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 term infants
- •birth weight 2500 - 4500 g
- •singleton birth
- •37 - 42 weeks gestation
排除标准
- •clinically significant abnormal findings (as determined by the investigator) on the physical examination or medical history
- •receiving medications other than vitamins
研究组 & 干预措施
Low Lactose Infant Formula
Other
干预措施: Low Lactose Infant Formula (Other)
结局指标
主要结局
Weight
时间窗: 16 weeks
次要结局
- Length gain(16 weeks)
- Occipital Head Circumference(16 weeks)
- Acceptability and Tolerability(16 weeks)
研究者
研究点 (6)
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