Exploratory/Proof of Principle Microbiota Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Fecal microbiota measured at each visit
研究概览
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
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
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
研究组 & 干预措施
Extensively hydrolyzed casein infant formula
干预措施: Extensively hydrolyzed casein infant formula (Other)
Mother's own breast milk
干预措施: Mother's own breast milk (Other)
Amino acid based infant formula
干预措施: Amino acid based infant formula (Other)
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)