Effect of Starter Formula With Symbiotic on Microbiota Balance
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 8
- 主要终点
- stool bacterial populations
研究概览
简要总结
The clinical trial aims at showing efficacy of prebiotics and the probiotic on microbiota balance. Together, the prebiotic solution in combination with the probiotic is expected to harmonize the microbiota of formula fed neonates with the microbiota of breast fed neonates and to allow a greater diversity of Bifidobacteria species in comparison with a formula non-supplemented with pre and probiotics.
详细描述
The infants will be recruited and randomized between 0 and 14 days. The intervention period, in terms of data necessary for the primary outcome, will be until they reach 3 months old. Measurements will be collected on three separate occasions during this period, i.e. 2 and 6 weeks and 3 months. Stools will be collected, on 3 separate occasions, i.e. 4-5 day, 6 weeks and 3 months of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy newborn infant
- •Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation)
- •Age of infant is between 14 days at the time of enrollment
- •Birth weight between 2500g and 4500g
- •For the Formula fed groups: The infant's mother has elected, before the 14th day of their child's life, not to continue breastfeeding (no breastfeeding after the 14th day of the child's life) For the Breastfed group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age
- •Having obtained his/her legal representative's informed consent
排除标准
- •Congenital illness or malformation that may affect normal growth
- •Significant pre-natal and/or post-natal disease
- •Re-hospitalization for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study).
- •Newborn who have received antibiotics during the first 14 days of life
- •Receiving infant formula containing pro and/or prebiotics at the time of enrolment
- •Newborn whose parents / caregivers cannot be expected to comply with treatment
- •Newborn currently participating in another clinical trial
结局指标
主要结局
stool bacterial populations
时间窗: 3 months
(Lactobacilli, Clostridia, Bacteroides, bifidobacteria, staphylococci, Enterobacteria and Bifidobacterial species at 1.5 months and 3 months of age of the infants.
次要结局
- changes in weight(3 months)
- Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)(3 months)
- changes in length(3 months)