NCT02500563
已完成
不适用
Exploratory/Proof of Principle Microbiota Study
Mead Johnson Nutrition1 个研究点 分布在 1 个国家目标入组 78 人2015年7月
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Fecal Microbiota
- 发起方
- Mead Johnson Nutrition
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Fecal microbiota measured at each visit
- 状态
- 已完成
- 最后更新
- 8年前
概览
简要总结
This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.
详细描述
This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.
研究者
入排标准
入选标准
- •Singleton, 1-7 days of age at registration or randomization
- •Term infant with appropriate birth weight for gestational age
- •Either solely formula fed or exclusively receiving mother's own breast milk
- •Signed Informed Consent and Protected Health Information
排除标准
- •Caesarean delivery
- •Infant was born from a mother with Type 1 diabetes
- •History of underlying metabolic or chronic disease or immunocompromised
- •Feeding difficulties or history of formula or human milk intolerance
- •Signs of acute infection of current use of antibiotics
结局指标
主要结局
Fecal microbiota measured at each visit
时间窗: 8 weeks
Sequencing and composition of samples
次要结局
- Body weight measured at each visit(8 weeks)
- Parental recall of formula intake at each visit(8 weeks)
- Body length measured at each visit(8 weeks)
- Head circumference measured at each visit(8 weeks)
- Serious adverse events collected throughout the study period(8 weeks)
- Stool collection at each visit(8 weeks)
研究点 (1)
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