NCT04059666终止不适用
Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas
Mead Johnson Nutrition10 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2019年3月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 57
- 试验地点
- 10
- 主要终点
- Comparison of stool microbiome between breast fed and formula fed babies
研究概览
简要总结
This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.
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
- 7 Days 至 18 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •7-18 days of age at Visit 1
- •Singleton birth
- •Gestational age of 37-42 weeks
- •Birth weight of 2500 g (5 lbs 8 oz) or more
- •Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
- •Signed informed consent and use of PHI for infant and birth mother
- •Receipt of three protocol-compliant Baseline stool samples
- •Infants receiving formula:
- •Exclusively receiving infant formula for at least 24 hours prior to randomization
- •Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period
- •Infants receiving human milk:
- •Mother has intention to exclusively provide mother's-own breast milk for the duration of the study
排除标准
- •Caesarean delivery
- •Infant consumption of donor milk prior to randomization/registration
- •Maternal antibiotic use within 48 hours prior to or at time of delivery
- •Maternal antibiotic use while providing mother's-own breast milk to infant
- •Infant use of systemic antibiotics prior to randomization/registration
- •Any signs of an acute infection (i.e. fever, diarrhea) at randomization/registration
- •Weight at Visit 1 is <95% of birth weight
- •Infant use of probiotics
- •Evidence of significant feeding difficulties
- •Infant was born large for gestational age
- •History of underlying metabolic or chronic disease or congenital malformation
- •Infant is immunocompromised
- •Infants receiving human milk:
- •Consumption of infant formula from 1 day of age
结局指标
主要结局
Comparison of stool microbiome between breast fed and formula fed babies
时间窗: Over 60 days
Stool collection
次要结局
- Stool molecules at each visit(Over 60 days)
- Stool color and consistency(3 times over 60 days)
- Oral microbiome at each visit(Over 60 days)
- 24 hour recall of formula intake(2 times over 60 days)
- Medically confirmed adverse events(60 days)
- Stool pH(Over 60 days)
研究者
研究点 (10)
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