NCT01897922已完成不适用
The Effects on Growth and Tolerance of an Infant Formula Fed to 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
- 348
- 试验地点
- 22
- 主要终点
- Body weight measured at each study visit
研究概览
简要总结
This clinical trial will evaluate an investigational infant formula with a probiotic to determine if it provides normal growth and if it is well tolerated by term infants compared to a marketed routine infant formula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 12 Days 至 16 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton, 12-16 days of age at randomization
- •Term infant with birth weight of a minimum of 2500 grams
- •Solely formula fed
- •Signed Informed Consent and Protected Health Information
排除标准
- •History of underlying metabolic or chronic disease or immunocompromised
- •Feeding difficulties or formula intolerance
研究组 & 干预措施
Marketed routine infant formula
Active Comparator
干预措施: Control: Marketed routine infant formula (Other)
Infant formula containing a probiotic source
Experimental
干预措施: An investigational infant formula containing a probiotic source (Other)
结局指标
主要结局
Body weight measured at each study visit
时间窗: 3.5 months
次要结局
- Medically-confirmed adverse events collected throughout the study period(3.5 months)
- Recall of infant formula intake at each study visit(3.5 months)
- Recall of stool consistency measured at each study visit(3.5 months)
- Parental Study Product Assessment Questionnaire completed at Study Visit 2(once)
- Head circumference measured at each study visit(3.5 months)
- Recall of gastrointestinal tolerance measured at each study visit(3.5 months)
- Body length measured at each study visit(3.5 months)
研究者
研究点 (22)
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