NCT03628183已完成不适用
Tolerance of Infants Fed a Hydrolysate Formula Manufactured With a New Processing Method
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
- 51
- 试验地点
- 10
- 主要终点
- Stool Characteristics
研究概览
简要总结
This is a prospective, randomized, multicenter study to assess the tolerance of 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
- Other
- 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
- •Subject is judged to be in good health
- •Singleton from a full-term birth
- •Birth weight was > or = to 2490 g
- •Between 0 and 14 days of age at enrollment
- •Parent(s) confirm their intention to feed their infant the assigned 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 from enrollment through the duration of the study
- •Subject's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF)
排除标准
- •An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- •Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
- •Subject participates in another study that has not been approved as a concomitant study
- •Subject has an allergy or intolerance to any ingredient in the study product
- •Subject has been treated with antibiotics within 2 weeks prior to enrollment
研究组 & 干预措施
Hydrolysate Infant Formula 1
Active Comparator
Ready to feed infant formula in can
干预措施: Hydrolysate Infant Formula 1 (Other)
Hydrolysate Infant Formula 2
Experimental
Ready to feed infant formula in bottle
干预措施: Hydrolysate Infant Formula 2 (Other)
结局指标
主要结局
Stool Characteristics
时间窗: Study Day 1 - Study Day 21
Parent completed diary
次要结局
- Length(Study Day 1 - Study Day 21)
- Formula Intake(Study Day 1 - Study Day 21)
- Weight(Study Day 1 - Study Day 21)
研究者
研究点 (10)
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