NCT00798382已完成2 期
Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 17
- 主要终点
- Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age.
研究概览
简要总结
The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.
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 with a gestational age of 37-42 weeks.
- •Infant's birth weight was > 2490 g (~5 lb 8 oz).
- •Infant is between 0 and 8 days of age at enrollment.
- •Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
- •Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant for the duration of the study.
- •Infants using medications or home remedies, herbal preparations or rehydration/intravenous (IV) fluids that might affect GI tolerance may not be enrolled.
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.
研究组 & 干预措施
1: Soy formula
Experimental
experimental soy formula #1
干预措施: soy protein formula (Other)
2: Soy Formula
Active Comparator
Commercially available soy formula
干预措施: Commercially available soy formula (Other)
3: Soy formula
Experimental
experimental soy formula #2
干预措施: Soy formula experimental #2 (Other)
结局指标
主要结局
Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age.
时间窗: 35 days
次要结局
- Additional gastrointestinal measures of tolerance from Study Visit 1 to Study Visit 3 at 35 days of age(35 days)
研究者
研究点 (17)
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