NCT01515644已完成3 期
A Randomized, Double-blind, Controlled Study on the Effect of Inulin on Gut Health of Infants
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Difference between beneficial bacteria I level in stool at week 4 and week 8.
研究概览
简要总结
In this study the effect of Infant formula with added Inulin will be compared with the effect of Infant formula without Inulin on the Bifidobacterium level in stool.
It is expected that drinking Infant formula with added Inulin will result in higher beneficial bacteria level in stool compared to an Infant formula without Inulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Difference between beneficial bacteria I level in stool at week 4 and week 8.
时间窗: Week 4, Week 8.
次要结局
- Difference between SCFA at week 4 and week 8.(Week 4, Week 8.)
- Difference between beneficial bacteria II level in stool at week 4 and week 8.(Week 4, Week 8.)
- Difference between pH of stool at week 4 and week 8.(Week 4, Week 8.)
- Difference between stool consistency at week 4 and week 8.(Week 4, Week 8.)
- Difference between sIgA at week 4 and week 8.(Week 4, Week 8.)
- Safety and tolerability.(From date of baseline visit (day 1) until the date of visit 8 (day 56))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
To Investigate Effects of a New Infant Formula in Healthy Term Chinese InfantsHealthy InfantsNCT03520764Danone Nutricia284
已完成
不适用
New Infant Formula Trial in Healthy Term Subjects on Growth, Body Composition, Tolerance and SafetyHealthyNCT01609634Danone Asia Pacific Holdings Pte, Ltd.541
已完成
不适用
A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected InfantsHIV InfectionsNCT00000873National Institute of Allergy and Infectious Diseases (NIAID)2,400
已完成
不适用
Effect of an Infant Formula With Synbiotics in Infants Born Via Caesarean SectionGut MicrobiotaNCT04991792HiPP GmbH & Co. Vertrieb KG486
已完成
不适用
Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified MilkFormula Feeding of Healthy Full Term InfantsNCT01197365Heinz Italia SpA148