NCT00977964已完成3 期
Tolerance of Healthy Term Infants Fed Infant Formulas
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 30
- 主要终点
- The primary variable is Gastrointestinal tolerance.
研究概览
简要总结
The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 8 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant is judged to be in good health.
- •Infant is a singleton from a full term birth.
- •Infant's birth weight was > 2490 g (~5 lbs 8 oz.
- •Infant is between 0 and 8 days of age at enrollment.
- •Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled.
- •Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
排除标准
- •An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- •Infant has been treated with antibiotics.
- •Infant has received probiotics.
结局指标
主要结局
The primary variable is Gastrointestinal tolerance.
时间窗: 1-28 days of age
次要结局
- The secondary variables are additional measures of GI tolerance and parental feedback.(1-28 days of age)
研究者
研究点 (30)
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