Growth of Infants Consuming Starter Formula Containing Synbiotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- mean weight gain
研究概览
简要总结
In this study the investigators want to evaluate the satiety of two infant formulas, one containing prebiotics and the other containing synbiotics. Rate of weight gain, a proxy measurement for the healthy development of an infant, will be assessed in both groups and compared to the growth observed in the WHO Child Growth Standards in order to demonstrate non inferiority.
详细描述
Growth studies continue to be a centrepiece of clinical evaluation of infant formulas. In order to standardize growth, the investigator proposes to calculate the weight-for-age Z-score related to the WHO Child Growth Standards. Z-scores express the difference between the measurement of an individual and the median value of the reference population as a proportion of the SD of the reference population taking into account age and gender.
The hypothesis to be tested is that infants fed with starter formula with prebiotics and probiotics blend and those fed only with probiotics will grow as much as infants in the reference growth of WHO.
Other parameters such as digestive tolerance, frequency of morbidity and microbiota pattern will also be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Days 至 17 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy newborn infant
- •Age at point of enrolment ≤14 days
- •Birthweight ≥2500g and ≤4500g
- •Full term infant ≥37 weeks gestation and ≤42 weeks gestation
- •Singleton births
- •Having obtained his/her or his/her legal representative's informed consent
排除标准
- •Congenital illness or malformation that may affect normal growth
- •Significant pre-natal or post-natal disease
- •Re-hospitalisation for more than 2 days during the first 14 days of life (Exceptionally, infants hospitalized because of jaundice may be enrolled in the study.)
- •Receiving infant formula containing probiotics and/or prebiotics prior to enrollment and/or at the time of enrollment
- •Patient who cannot be expected to comply with treatment
- •Currently participating or having participated in another clinical trial prior to the beginning of this study
结局指标
主要结局
mean weight gain
时间窗: 6 months
次要结局
- digestive tolerance(6 months)