NCT01731392已完成不适用
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Milk-based Formulas on Infections and Immune Functions in Healthy Children
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 604 人开始时间: 2012年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 604
- 试验地点
- 1
- 主要终点
- Days with diarrhea
研究概览
简要总结
To investigate the effect of milk-based formulas on infections and immune functions in healthy children.
详细描述
Particular attention was paid to the role played by nutrition in supporting the gut ecosystem, balancing microbiota and promoting health status. In that respect, the beneficial effects of probiotics were demonstrated for different infectious diseases, GII and URI.
The beneficial effect of probiotics for treatment of symptomatic diarrhea was clearly documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents written and signed informed consent for participation in the study.
- •Healthy children aged 1 to 3 years that are no more breastfed.
- •Go to a selected nursery and / or pediatrician.
- •Parents must have a phone at home or a cellular phone to call the paediatrician.
- •No consumption of commercial products containing probiotics or prebiotics during the 3 weeks before and during the study period.
- •Parents are able to give their children, twice daily, 2 milk servings on a 5 months period.
- •Children not being intensive consumers of regular yoghurts
排除标准
- •Rotavirus and flu vaccines administration within the last 3 months prior to V1 (baseline visit).
- •Used antibiotics within the last 30 days prior to V1 (baseline visit).
- •Congenital or chronic disease.
- •Any kind of immunodeficiency or allergy, milk protein allergy or lactose intolerance.
- •Significant illness within the two weeks prior to start of the study or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.
结局指标
主要结局
Days with diarrhea
时间窗: during the 5 months of follow up
次要结局
- Number of episodes of Upper Respiratory Infections(5 months)
- Duration of episodes of Upper Respiratory Infections(5 months)
- Severity of episodes of Upper Respiratory Infections(5 months)
研究者
研究点 (1)
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