NCT01476397已完成不适用
ASSESSMENT OF GROWTH OF INFANTS FED FORMULA WITH PROBIOTICS
Société des Produits Nestlé (SPN)16 个研究点 分布在 1 个国家开始时间: 2011年12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
- 试验地点
- 16
- 主要终点
- growth
研究概览
简要总结
This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.
研究设计
- 研究类型
- Interventional
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
- •Full-term
- •Birth weight > 2500 and < 4500 g
- •14±3 days of age on enrollment
- •Exclusively formula-fed, singleton birth
- •Having obtained his/her legal representative's informed consent
排除标准
- •Known or suspected cow-milk allergy
- •Congenital illness or malformation that may affect infant feeding and/or growth
- •Significant prenatal and/or postnatal disease
- •Any readmission to hospital prior to enrollment
- •Receiving prescription medication or frequent use of over the counter medications except vitamin and mineral supplements
- •Has received intravenous antibiotic therapy or oral probiotic in the last 7 days
- •Currently participating in another clinical study
- •Cannot be expected to comply with treatment
结局指标
主要结局
growth
时间窗: 4 months
weight gain assessed monthly
次要结局
- other growth(4 months)
- stool characteristics(throughout study)
- adverse events(4 months)
- spit-up(throughout study)
- vomit(throughout study)
研究者
研究点 (16)
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