NCT02322138已完成不适用
Gastrointestinal Tolerance of Formula Supplemented With Prebiotics
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
- 131
- 试验地点
- 10
- 主要终点
- Stool Consistency Questionnaire
研究概览
简要总结
The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 lbs 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 (formula-fed infants) or human milk (human milk-fed infants) 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.
排除标准
- •Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development.
- •Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance.
- •Mother intends to use a combination of breast and formula feeding.
- •Participation in another study that has not been approved as a concomitant study by AN.
研究组 & 干预措施
Experimental 1 Infant Formula
Experimental
Milk-based infant formula without prebiotics
干预措施: Experimental 1 Infant Formula (Other)
Experimental 2 Infant Formula
Experimental
Milk-based infant formula with prebiotics
干预措施: Experimental 2 Infant Formula (Other)
Human Milk-Fed Reference Group
Other
Breast fed infants
干预措施: Reference Group (Other)
结局指标
主要结局
Stool Consistency Questionnaire
时间窗: Baseline to 35 Days of Age
Questionnaire
次要结局
- Length(Baseline to 35 Days of Age)
- Feeding Spit Up Questionnaire(Baseline to 35 Days of Age)
- Weight(Baseline to 35 Days of Age)
- Head Circumference(Baseline to 35 Days of Age)
- Stools per Day Questionnaire(Baseline to 35 Days of Age)
研究者
研究点 (10)
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