NCT02710955已完成不适用
Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of episodes of regurgitation per day
研究概览
简要总结
The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Week 至 5 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants :
- •Aged ≤ 5 months old
- •fully formula fed
- •with at least 5 episodes of regurgitation per day, for at least a week
排除标准
- •Breast fed infants
- •Infants presenting symptoms of a complicated gastroesophageal reflux
- •Infants presenting intestinal disorders
研究组 & 干预措施
Thickened infant formula
Experimental
干预措施: Thickened infant formula (Dietary Supplement)
结局指标
主要结局
Number of episodes of regurgitation per day
时间窗: 14 days
次要结局
- Stools frequency over 72h(14 and 90 days)
- Stools consistency assessed through Bristol Stool form Scale(14 and 90 days)
- Weight expressed in z scores according to the WHO Child Growth Standards(90 days)
- Height expressed in z scores according to the WHO Child Growth Standards(90 days)
- Regurgitation score assessed through Vandenplas score(14 and 90 days)
- BMI expressed in z scores according to the WHO Child Growth Standards(90 days)
- Head circumference expressed in z scores according to the WHO Child Growth Standards(90 days)
研究者
研究点 (1)
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