NCT02670863已完成不适用
Safety and Efficacy of a New Term Infant Formula Supplemented With A Prebiotic: a Doubleblind, Randomized, Controlled Trial
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 239 人开始时间: 2016年1月21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
- 239
- 试验地点
- 2
- 主要终点
- Stool Consistency Score
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula.
详细描述
Randomized, double-blind, controlled interventional clinical trial design. The purpose of this study is to evaluate the safety and efficacy of a new term infant formula supplemented with a prebiotic vs a standard infant formula fed for 150 days to healthy, term infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Days 至 26 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written Informed Consent
- •Infants whose parent(s)/LAR have reached the legal age of majority in the Philippines
- •Infants whose parent(s)/LAR are willing and able to comply with study requirements
- •Infants whose parent(s)/LAR are able to be contacted by telephone throughout the study
- •Healthy term, singleton infant at birth
- •Between 21 to 26 days post-natal age at enrollment visit
- •Weight-for-length and head circumference-for-age z-scores >/= - 3 and </= +3 according to WHO Child Growth Standards
- •Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment
排除标准
- •Infants with conditions requiring infant feedings other than those specified in the protocol
- •Infants receiving complementary foods or liquids
- •Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
- •Infants who are presently receiving or have received medications that could interfere with the interpretation of study results
- •Infants or infants whose parents/LAR cannot be expected to comply with the protocol or with study procedures
结局指标
主要结局
Stool Consistency Score
时间窗: 150 days
Growth
时间窗: 150 days
weight gain velocity
次要结局
- Weight(150 days)
- Average Daily Stool Frequency(150 days)
- Fecal Microbiota(150 days)
- Fecal Markers(150 days)
- Adverse Events(150 days)
研究者
研究点 (2)
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