NCT02456831已完成不适用
Efficacy of Soy Formula Feedings in Healthy, Term Infants
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
- 115
- 试验地点
- 7
- 主要终点
- Stool Characteristics Questionnaire
研究概览
简要总结
This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.
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
- 2 Weeks 至 9 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy infants believed by their parents and/or physicians to be experiencing symptoms of cow's milk formula intolerance and who had not previously consumed a soy-based formula (Intervention subjects).
- •Health infants reported to be tolerating a milk-based formula (Cohorts).
- •Infants considered full-term, 2 to 9 weeks of age with a birth-weight above the 5th percentile (NCHS).
排除标准
- 未提供
研究组 & 干预措施
Control Infant Formula
Active Comparator
Ready-to-Feed (RTF) Soy Infant Formula
干预措施: Active Comparator: Control Infant Formula (Other)
Experimental Infant Formula 1
Experimental
Experimental Ready-to-Feed Soy Formula
干预措施: Experimental Infant Formula 1 (Other)
Experimental Infant Formula 2
Experimental
Experimental Ready-to-Feed Soy Formula
干预措施: Experimental Infant Formula 2 (Other)
Experimental Infant Formula 3
Experimental
Experimental Ready-to-Feed Soy Formula
干预措施: Experimental Infant Formula 3 (Other)
结局指标
主要结局
Stool Characteristics Questionnaire
时间窗: Change from Baseline (Study Day 1) to Study Day 15
stool number, consistency, and color
次要结局
- Gastrointestinal Tolerance Questionnaire(Change from Baseline (Study Day 1) to Study Day 15)
- Weight(Change from Baseline (Study Day 1) to Study Day 15)
- Formula Intake(Change from Baseline (Study Day 1) to Study Day 15)
研究者
研究点 (7)
Loading locations...
相似试验
已完成
不适用
Gastrointestinal Tolerance of Infant FormulaGastrointestinal ToleranceNCT02322138Abbott Nutrition131
已完成
2 期
Tolerance of Healthy, Term Infants to Infant FormulasHealthyNCT00543673Abbott Nutrition180
已完成
1 期
Phase I study for the safety of soy milk yoghurt feeding therapy in the patients with food allergyFood allergyJPRN-UMIN000028599Department of Dermalogy Shimane university, Faculty of Medicine12
已完成
不适用
Isomil Post Marketing Observational StudyCow's Milk AllergyNCT01809951Melva Louisa534
已完成
不适用
Tolerance of Healthy Infants Fed Infant FormulasGastrointestinal ToleranceNCT02401217Abbott Nutrition126