Evaluation of Nutritional Suitability and Tolerability of a Human Milk Oligosaccharide (HMO) Mix in Infant Formula for Term Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 340
- 试验地点
- 18
- 主要终点
- assessment of body weight (in grams) of term infants
研究概览
简要总结
The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the sole source of nutrition.
详细描述
The main goal of the study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth of term infants (evaluated per weight gain, body length and head circumference), in comparison with infant formula without human milk oligosaccharides, when the formula is fed exclusivly in the first four month of life. Additionally, a comparison of the two formula fed groups against a reference group with breastfed infants as well as the WHO growth standard reference tables will be performed. An assessment of safety and tolerability will be performed as well.
As a secondary out come of the study, we will examine the effect of the formula on the infant microbiome, as well as the HMO status of the mother's milk towards the microbial composition of the infant microbiome.
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 (Care Provider)
入排标准
- 年龄范围
- 1 Day 至 13 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton birth
- •Full-term infant (37 - 42 weeks of gestational age)
- •APGAR score of 9 or 10
- •Birth weight 2500 - 4500 g
排除标准
- •clinically significant condition/ disorder
- •Adverse maternal of fetal medical history that may influence growth/development of the subject or tolerance of the infant formula
- •readmission to hospital (except for hyperbilirubinemia)
- •allergy to cow's milk
- •participation in another study
结局指标
主要结局
assessment of body weight (in grams) of term infants
时间窗: 4 month
growth, assessed by body weight gain, of term infants from enrollment to 4 month of life
次要结局
- assessment of body length (in centimeter) of term infants(4 month)
- assessment of head circumference (in centimeter) of term infants(4 month)