NCT02431377已完成不适用
Acceptability and GI Tolerance of an Alpha-lactalbumin-enriched Formula: An Uncontrolled, Open-label, Descriptive Study
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年4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
- 40
- 试验地点
- 2
- 主要终点
- Infant Gastrointestinal Symptom Questionnaire Composite Index Score
研究概览
简要总结
A single center, non-controlled trial to document the gastrointestinal (GI) tolerability of the study formula (SF), containing a whey protein concentrate enriched with alpha-lactalbumin (WPC alpha-lac) fed for 6 weeks to healthy, term infants.
详细描述
The purpose of this study is to examine the tolerable and acceptability of an infant formula with with a Whey protein concentrate containing alpha-lactalbumin as measure by GI tolerance, and eating behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 21 Days 至 35 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Healthy, full term, singleton infant
- •Be between 28±7 days post-natal age
- •Infants at enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables / charts
- •Infants must be exclusively consuming and tolerating a cow's milk infant formula for a minimum of 3 consecutive days and parent(s)/LAR must have previously made the decision to continue to exclusively formula feed
- •Have sufficient command of Tagalog or English language to complete the informed consent and other study documents
- •Are willing and able to fulfill the requirements of the study protocol
- •Have reached the legal age of consent in the Philippines
- •Able to be contacted by telephone throughout the study
排除标准
- •Infants who are receiving any amount of supplemental human milk
- •Family history of siblings with documented cow's milk protein intolerance/allergy
- •Conditions requiring infant feedings other than those specified in the protocol
结局指标
主要结局
Infant Gastrointestinal Symptom Questionnaire Composite Index Score
时间窗: 6 weeks
次要结局
- Formula Intake volume(6 weeks)
- Stool Consistency Score(6 weeks)
- Infant Toddler Quality of Life Profile(6 weeks)
- Baby Eating Behaviour Questionnaire Profile(6 weeks)
- Infant Characteristics Questionnaire (ICQ) Profile(6 weeks)
研究者
研究点 (2)
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