The Role of Milk Fat Globule Membrane and 2'-Fucosyllactose in the Infant Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Change from baseline in microbial DNA in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.
研究概览
简要总结
This study will compare infant gut bacteria for infants who have been fed a standard infant formula (Enfamil Infant); infants who have been fed a new infant formula designed to be more similar to breast milk (Enfamil NeuroPro); and breastfed infants. These formulas are currently available on the market and meet FDA requirements for infant formula.
详细描述
This study is a randomized, double-blind, parallel-group study comparing breast milk to Enfamil Infant and Enfamil NeuroPro formulas. The central hypothesis of the study is that the addition of milk fat globule membrane and2'-Fucosyllactose (2'-FL) to infant formula plays a role in shaping the microbiota in a manner similar to the microbiota of breastfed infants. To test this hypothesis, the investigators will explore longitudinal changes in the fecal microbiome from birth to 4 months of age in infants fed breast-milk, standard Enfamil Infant formula or Enfamil NeuroPro formula. Fecal samples will be collected at birth, and then monthly for 4 months. At the time of last collection one serum sample will be collected. The investigators will analyze basic growth parameters, fecal microbial community analysis by metagenomics, fecal metabolome by untargeted metabolomic analysis, and fecal and systemic indicators of inflammation and intestinal barrier function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants and research nurse/coordinator will be blinded to the formula assignment. The formulas used will be a standard infant formula (Enfamil Infant) and a new infant formula designed to be more similar to breast milk (Enfamil NeuroPro); both formulas are available for purchase by the public and meet FDA requirements for infant formulas. Each formula can (identical size) will be relabeled and coded by the investigators. Participants in the formula group will be provided with a four-month supply of powdered formula at the time of discharge from the hospital, along with stool collection kits.
入排标准
- 年龄范围
- 0 Months 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term infants with parental consent
- •Parents are able to provide informed consent; own a smart phone and are able to fill out weekly digital questionnaires.
排除标准
- •Prematurity (<= 36 weeks gestational age)
- •Babies born through c-section
- •Any health issues identified at the first postpartum screening
- •Use of both breast milk and formula
- •Use of donor breast milk
- •Parent unwillingness/inability to avoid giving prebiotics, probiotics, symbiotics, and immune-stimulating products to the child for the duration of this study
结局指标
主要结局
Change from baseline in microbial DNA in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.
时间窗: Birth to 4 months
Assessed using 16S amplicon profiling of stool samples
Change from baseline in the gut metagenomics in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.
时间窗: Birth to 4 months
Samples sequenced using the NextSeq 500/550 and mapped against functional reference sequence databases using Bowtie2
Change from baseline of metabolome in term infants fed Enfamil NeuroPro as compared to standard Enfamil Infant formula or breast milk.
时间窗: Birth to 4 months
Untargeted analysis by automated comparison of the ion features in the experimental samples to a reference library of chemical standard entries.
次要结局
- Growth- Weight(Birth to 4 months)
- Growth- Height(Birth to 4 months)
- Growth- Head circumference(Birth to 4 months)