A Randomized, Parallel, Double Blind, Placebo Controlled Clinical Study Evaluating the Effect of Probiotic Formula on Immune System in Preschool Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 10
- 主要终点
- The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group
研究概览
简要总结
Healthy preschool children will be recruited, gastrointestinal infection and respiratory infection symptoms will be followed during the 8-week treatment and 4-week follow-up period, to evaluate the effect of the used probiotic formula on immune system in comparison to the group using placebo.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •signed informed consent by at least one parent or legal guardian
- •children aged 2 to 6 years
- •attending or about to start attending day-care
排除标准
- •body weight at birth <2500g
- •gestational age <37 weeks
- •severe chronic illness
- •regular use of medication
- •immunodeficiency
- •parent or legal guardian not able to understand and comply with requirements of the study
研究组 & 干预措施
Experimental group
Probiotic DE111®
干预措施: Probiotic Formula Bacillus subtilis DE111® (Dietary Supplement)
Control group
Placebo
干预措施: Placebo comparator (Dietary Supplement)
结局指标
主要结局
The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group
时间窗: 12-week study period (consisting of 8-week treatment plus 4-week follow-up)
Number of participants with at least one occurrence of gastrointestinal and/or respiratory infections during 12-week study period in the experimental group compared to control group.
The incidence of adverse events occuring in the experimental group compared to control group
时间窗: 12-week study period (consisting of 8-week treatment plus 4-week follow-up)
Number of participants with treatment related adverse events during 12-week study period for both, experimental and control group.
次要结局
未报告次要终点