NCT04529759已完成不适用
Tolerance of Healthy Term Infants Fed Milk-Based Infant Formula With Oligosaccharides
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 12
- 主要终点
- Mean rank stool consistency (MRSC)
研究概览
简要总结
This is a randomized, controlled, double-blind, parallel, feeding study with the purpose to evaluate the tolerance of healthy term infants fed partially hydrolyzed whey protein 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Good health as determined from participant's medical history
- •Singleton from a full-term birth with a gestational age of 37-42 weeks
- •Birth weight was > 2490 g (~5 lbs. 8 oz.)
- •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, (except for vitamin D supplements if instructed by their healthcare professional), solid foods or juices to their infant from enrollment through the duration of the study
- •Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) 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 participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development
- •Participant is taking and plans to continue taking medications (including over the counter (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
- •Participant is enrolled in another study that has not been approved as a concomitant study
结局指标
主要结局
Mean rank stool consistency (MRSC)
时间窗: Study Day 1 to 28 Days of Age
Parent Completed Diary
次要结局
- Weight(14 to 119 Days of Age)
- Gastrointestinal tolerance(14 to 119 Days of Age)
- Length(14 to 119 Days of Age)
- Head Circumference(14 to 119 Days of Age)
研究者
研究点 (12)
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