NCT02948114终止不适用
The Effect of Feeding Infant Formula Containing Prebiotics and/or Probiotics
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in fecal microbiota
研究概览
简要总结
The study is intended to evaluate the microorganisms found in infant stools when consuming study formulas containing prebiotics and/or probiotics compared to infants consuming mother's own breast milk.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 10 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton, 10-14 days of age at registration/randomization
- •Term infant with birth weight of 2500 grams or more from a vaginal birth
- •Formula feeding infants must be on formula for at least 3 days
- •Human milk fed infants must have received mother's own breast milk from 1 day of age to study registration and mother has intention to exclusively provide mother's own breast milk for the duration of the study
- •Signed informed consent
排除标准
- •History of underlying metabolic or chronic disease or immune compromised
- •Feeding difficulties or formula intolerance
研究组 & 干预措施
Control: Cow milk-based infant formula
Active Comparator
Cow milk-based infant formula
干预措施: Control: Cow milk-based infant formula (Other)
Experimental 1: Cow milk-based infant formula
Experimental
Cow milk-based infant formula with prebiotics
干预措施: Experimental 1: Cow milk-based infant formula (Other)
Experimental 2: Cow milk-based infant formula
Experimental
Cow milk-based infant formula with probiotics
干预措施: Experimental 2: Cow milk-based infant formula (Other)
Experimental 3: Cow milk-based infant formula
Experimental
Cow milk-based infant formula with prebiotics and probiotics
干预措施: Experimental 3: Cow milk-based infant formula (Other)
Human Milk Reference
No Intervention
Human Milk Reference
结局指标
主要结局
Change in fecal microbiota
时间窗: 3.5 months
次要结局
- Body Length measured at each study visit(Up to 3.5 months)
- Recall of infant formula usage at each study visit(Up to 3.5 months)
- Body Weight measured at each study visit(Up to 3.5 months)
- Recall of gastrointestinal tolerance questionnaire at each study visit(Up to 3.5 months)
- Medically-confirmed adverse events collected throughout the study period(Up to 3.5 months)
- Head circumference measured at each study visit(Up to 3.5 months)
研究者
研究点 (1)
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