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
干预措施
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
- •at screening:
- •Healthy infants between 3-4 months (91-120 days after birth) of age at day 1 of the study, with healthy growth determined based on WHO standard
- •Fully formula-fed in the 28 days prior to inclusion
- •Expected investigational product intake of min 500ml per day
- •Written informed consent from the parents
排除标准
- •at screening:
- •Low birth weight (LBW) less than 2,000g.
- •Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special toddler formula is required)
- •Use of systemic antibiotics or antimycotics medication in the 14 days prior to the study
- •Significant congenital abnormality that will interfere with the study objectives in the opinion of the investigator.
- •Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
- •Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
- •Exclusion criteria for intervention period:
- •Not consuming study product longer than 2 days consecutively
- •Intake of study product is less than 500ml per day for 7 days
研究组 & 干预措施
Intervention group I
Experimental
Intervention group I: Powder based Infant formula with Inulin I
干预措施: Powder based infant formula (Other)
Intervention group II
Experimental
Intervention group II: Powder based Infant formula with Inulin II
干预措施: Powder based infant formula (Other)
Intervention group III
Placebo Comparator
Intervention group III: Powder based Infant formula without Inulin
干预措施: Powder based infant formula (Other)
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 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.)
- Difference between SCFA 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)
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