NCT00543673已完成2 期
Tolerance of Healthy, Term Infants to Infant Formulas
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 10
- 主要终点
- Mean rank stool consistency (MRSC)
研究概览
简要总结
To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control 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
- •judged to be in good health.
- •singleton from a full term birth with a gestational age of 37-42 weeks
- •birth weight was > 2490 g (~5 lbs 8 oz)
- •between 0 and 8 days of age at enrollment.
- •Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
排除标准
- •An adverse maternal, fetal or infant medical history thought by the investigator to have potential for effects on tolerance, growth, and/or development, including, but not limited to suspected maternal substance abuse.
- •Infant has been treated with antibiotics.
研究组 & 干预措施
Milk based formula A
Experimental
Experimental milk based infant formula
干预措施: Milk based formula A (Other)
Standard formula
Active Comparator
standard milk based infant formula
干预措施: #2 Standard formula (Other)
Reference
Other
Human milk
干预措施: #3 Human Milk (Other)
Milk based formula C
Experimental
Experimental milk based infant formula
干预措施: Milk based formula C (Other)
结局指标
主要结局
Mean rank stool consistency (MRSC)
时间窗: Study Day 1 to Visit 3
次要结局
- MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting(4 months)
研究者
研究点 (10)
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