NCT01488435已完成不适用
Efficacy and Tolerance of a Follow-On Formula Fed to Children From 36-48 Months of Age
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
- 310
- 试验地点
- 1
- 主要终点
- Acute respiratory infections and diarrheal disease
研究概览
简要总结
The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.
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
- 36 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child 36-48 months of age
- •Child is currently attending a daycare and has attended for 6 months or less
- •Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization
- •Signed informed consent
排除标准
- •Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization
- •Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child
- •Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization
- •Child's z-score of weight for height < -3 according to World Health Organization criteria
研究组 & 干预措施
Follow-On Formula
Experimental
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
干预措施: Follow-On Formula (Dietary Supplement)
Cow's Milk
Placebo Comparator
Powdered whole cow's milk
干预措施: Cow's milk (Dietary Supplement)
结局指标
主要结局
Acute respiratory infections and diarrheal disease
时间窗: 28 weeks
次要结局
- Allergic manifestations(28 weeks)
- Systemic antibiotic use(28 weeks)
- Duration of acute respiratory infection and diarrheal disease(28 weeks)
- Changes in stool patterns(Baseline and 28 weeks)
- Fecal immune markers(Baseline and 28 weeks)
- Serum Ferritin status(Baseline and 28 weeks)
- Incidence of stool parasites(Baseline and 28 weeks)
- Growth(28 weeks)
- Adverse events(28 weeks)
- Acceptance of study product(28 weeks)
- Serum immune markers(Baseline and 28 weeks)
- Serum zinc status(Baseline and 28 weeks)
研究者
研究点 (1)
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