The Impact of a Prebiotics and Lactoferrin Containing Infant Formula on Stool Characteristics in Healthy Term Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- growth
研究概览
简要总结
Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated colonic microflora.The purpose of this study is to investigate the stool characteristics,acceptability, and gastrointestinal tolerance in term infants fed a starting infant formula supplemented with prebiotics and lactoferrin.
详细描述
Human milk (HM) is considered the gold standard nutrient for infants, which contains a lot of beneficial nutrients such as prebiotics and lactoferrin. Previous studies have shown that both prebiotics and lactoferrin play important roles in generating a bifidobacteria-dominated colonic microflora as well as the intestinal immune systems. The purpose of this study is to investigate the stool characteristics（including intestinal microbiota） acceptability, and gastrointestinal tolerance in infants fed a starting infant formula supplemented with prebiotics and lactoferrin, and compared these data with infants on exclusively breast feeding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 5 Weeks 至 7 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •full-term with a birth weight ≥2,500 g
- •be in good health
- •without symptoms of diarrhea, and had not received antibiotics for at least 1 week before enrollment
- •exclusively fed by breast milk or infant formula
排除标准
- •preterm infant
- •with known diseases or currently taking medication drugs
- •mixed feeding
- •with symptoms of diarrhea
- •received antibiotics within 1 week
结局指标
主要结局
growth
时间窗: 6 weeks
Head circumferences and weight gain
次要结局
- Gastrointestinal tolerance and safety(6 weeks)
- intestinal microbiota(6 weeks)
研究者
Jiang WU
MD
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine