NCT03223792已完成不适用
Acceptance Of A Partially-Hydrolyzed Infant Formula
Mead Johnson Nutrition22 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年8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
- 100
- 试验地点
- 22
- 主要终点
- Stool consistency measured by MJN stool consistency scale
研究概览
简要总结
This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 28 Days 至 300 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton 28-300 days of age at randomization
- •Gestational age less than or equal to 35 weeks
- •Receiving minimum 18oz infant formula in the 24hrs prior to randomization
- •History of hard stools or stooling difficulty
- •Signed informed consent and protected health information
排除标准
- •Current diagnosis of cow's milk protein allergy or intolerance
- •Use of extensively hydrolyzed or amino acid formula at randomization
- •Any abdominal or gastrointestinal surgery prior to randomization
- •History of underlying metabolic or chronic disease or congenital malformation
- •Organic causes of constipation
结局指标
主要结局
Stool consistency measured by MJN stool consistency scale
时间窗: 14 days
次要结局
- Bowel movement characteristics by diary(14 days)
- Stool frequency(14 days)
- Formula acceptance measured by intake diary(14 days)
- Formula gastrointestinal tolerance measured by diary(14 days)
- Medically confirmed adverse events throughout the study period(14 days)
研究者
研究点 (22)
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