NCT02340143已完成不适用
Assessing Early Behavioral Indicators of Formula Tolerance
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
- 71
- 试验地点
- 1
- 主要终点
- Infant Behavior Diary
研究概览
简要总结
The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton at birth
- •Term infant with birth weight of 2500 g or more
- •Crying or fussing for 3 or more hours per day
- •Consuming mostly infant formula
- •Signed Informed Consent and Protected Health Information authorization
排除标准
- •Current use of extensively hydrolyzed or amino acid infant formula
- •Planned use of probiotics during the study
- •History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
- •Enrollment in another interventional clinical research study
研究组 & 干预措施
Control
Active Comparator
Marketed partially hydrolyzed cow's milk protein infant formula
干预措施: Control (Other)
Investigational
Experimental
Partially hydrolyzed cow's milk infant formula with a probiotic
干预措施: Investigational (Other)
结局指标
主要结局
Infant Behavior Diary
时间窗: 21 Days
次要结局
- Infant Behavior Questionnaire - Revised(Baseline and Day 21)
- Recall of Tolerance Questionnaire(Baseline and Day 21)
- Body Weight(Baseline and Day 21)
- Recall of formula intake at each visit(Baseline, Day 10, and Day 18)
- Fecal microbiome and Fecal calprotectin(Baseline and Day 21)
- Medically-confirmed Adverse Events(21 Days)
研究者
研究点 (1)
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