A Clinical Study on The Effect of Probiotic Compound Powder (WONDERLAB) on The Immunity Improvement of Preschool Children (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Infection of the upper respiratory tract at baseline
研究概览
简要总结
This is a randomized controlled trial, to evaluate the effect of WONDERLAB Probiotic Compound Powder on improving immunity of preschool children
详细描述
The community hospital will recruit 140 preschool children, aged 5 to 6 years old, according to the inclusion and exclusion criteria, and randomly assigned them to 2 groups. 70 subjects in the placebo group and 70 in the experimental product group.
First entered a one-week washout period, and then entered a 25-week clinical intervention, and finally ensured that 100 volunteers completed the whole study, and the withdrawal rate was about 28%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 5 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preschool children, male or female, 5 to 6 years old;
- •Those with weak constitution and easy to get sick:
- •One of them can be satisfied:
- •AGet cold ≥ 3 times a year B Bronchitis or pneumonia ≥2 times per year C Rotavirus diarrhea ≥1 time per year
- •During the trial, participants agree not to take any drugs, supplements, or other dairy products containing probiotics;
- •During the trial, participants agree not to take any other prebiotic/bacterial drugs, supplements, or dairy products including yogurt drinks;
- •Willing to refrain from participating in other interventional clinical studies during the trial period;
- •Be able to fully understand the nature, purpose, benefits and possible risks and side effects of the research;
- •Willing to obey all test requirements and procedures;
- •Informed consent signed by parents or legal guardians.
排除标准
- •Subject who is in the treatment of gastrointestinal diseases;
- •Subject who has lactose intolerance;
- •The subjects are currently suffering from other organic diseases that affect intestinal function, such as history of gastrointestinal resection, colonic or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, Hirschsprung's disease, scleroderma, anorexia nervosa, etc.;
- •Subjects have any of the following medical histories or clinically diagnosed diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases;
- •According to the judgment of the researchers, frequent use of drugs that may affect gastrointestinal function or the immune system;
- •Subjects who took laxatives or other digestive aids 2 weeks before the start of the study;
- •Consumed dairy products or other foods containing prebiotics/bacteria within 10 days before the start of the study;
- •PI believes that volunteers cannot fully cooperate with the trial arrangement.
结局指标
主要结局
Infection of the upper respiratory tract at baseline
时间窗: baseline(day 0)
Drug records of upper respiratory tract infection within past 12 months.
Rotavirus diarrhea Testing at baseline
时间窗: baseline(day 0)
Records of sick leave days, medical visits and hospitalization days due to rotavirus infection within past 12 month
Rotavirus diarrhea Testing at endpoint
时间窗: endpoint( day 168)
Records of sick leave days, medical visits and hospitalization days due to rotavirus infection within past 168 days
Infection of the upper respiratory tract at endpoint
时间窗: endpoint ( day 168)
Drug records of upper respiratory tract infection within past 168 days.
次要结局
- Saliva(baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175))
- Bristol Stool Chart(baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175))
- Faeces(baseline(day 0)/interim ( day 84)/endpoint( day 168)/recession period( day 175))
- Pittsburgh sleep quality index(baseline(day 0)/interim ( day 84)/endpoint( day 168))