NCT01373541已完成不适用
Effect of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Infants in China: a Double Blind, Multi-center, Randomized, Controlled Trial
Enzymotec1 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2011年5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
- 171
- 试验地点
- 1
- 主要终点
- Soaped and total fatty acids content in infant's stool samples collected at the age of 6 weeks and measured by stool biochemistry analysis
研究概览
简要总结
The purpose of this study is to determine the effect of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) on improving fat absorption and general gastrointestinal tolerance in Chinese formula-fed term infants.
详细描述
The purpose of this study is to assess the efficacy of infant formula with high percentage of palmitic acid at the sn-2 position (InFat™) as compared to standard vegetable oil based infant formula on general gastrointestinal tolerance and fat absorption, reducing calcium soaps formation and stool hardness in Chinese formula-fed 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
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Day 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parental/legal guardian written informed consent;
- •The mother had unequivocally decided not to breast-feed (for formula fed infants) or to breastfeed (for human milk fed infants).
- •Term infant of Chinese origin born at 37-42 gestation weeks
- •Birth weight appropriate for gestational age (AGA), 2500-4000grams
- •The infant is apparently healthy at birth and entry of study.
排除标准
- •Adverse maternal, fetal or infant medical history that can potentially affect efficacy parameters, tolerance, growth and/or development
- •The infant is not a singleton newborn
结局指标
主要结局
Soaped and total fatty acids content in infant's stool samples collected at the age of 6 weeks and measured by stool biochemistry analysis
时间窗: 6 postnatal weeks
次要结局
- Number of participants with adverse events and concomitant medications as a measure of safety and tolerability(Baseline, 6,12 and 24 postnatal weeks)
- Anthropometric parameters: body length, body weight, and head circumferences at each visit(Baseline, 6, 12 and 24 postnatal weeks)
- Dietary, stool consistency and well being recorded by 3 day questionnaires(6, 12 and 24 postnatal weeks)
- Bone speed of sound measured by ultrasonic device at each visit(Baseline, 6,12 and 24 postnatal weeks)
研究者
研究点 (1)
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