NCT01880970已完成不适用
Effect of Starter Formula With Synbiotics on Prevention of Gastro-intestinal Infections and All Infections With Fever in Full Term Infants
Société des Produits Nestlé (SPN)14 个研究点 分布在 3 个国家目标入组 477 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 477
- 试验地点
- 14
- 主要终点
- Diarrhea and all infections with fever
研究概览
简要总结
The aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 12 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 ≤ 13 days at the time of enrollment
- •Birth weight ≥ 2500g and ≤ 4500g
- •For the FF groups: The infant's mother has elected not to breastfeed
- •For the BF 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 (especially immunodeficiencies)
- •Significant pre-natal and/or post-natal diseases
- •Perinatal antibiotic or infants on antibiotics at the time of inclusion
- •Infants whose mother has had an acute infection during the last month of pregnancy
- •Re-hospitalisation 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)
- •Receiving infant formula containing probiotics and/or prebiotics at the time of enrollment
- •Newborn whose parents / caregivers cannot be expected to comply with treatment
- •Newborn currently participating in another interventional clinical trial
结局指标
主要结局
Diarrhea and all infections with fever
时间窗: over 6 months and 1 year
Mean event rate of diarrhea and all infections with fever per child over 6 months and 1 year
次要结局
- Morbidity(over 6 months and 1 year)
- Anthropometry(until 1 year)
- Digestive tolerance(until 1 year)
- Stool characteristics(at 3 and 6 months)
研究者
研究点 (14)
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