Role of Probiotics in Prevention of Respiratory Tract Infections in Preschool and Primary School Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- Incidence of respiratory tract infection episodes in a child
研究概览
简要总结
The purpose of this study is to assess the potential of probiotics in prevention of respiratory tract infections and their complications in children
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 3-12 yrs
- •At least one episode of respiratory tract infection in the previous epidemiological season
- •Direct telephone access available
- •Informed consent signed
排除标准
- •Vaccination against the influenza
- •Chronic adeno-tonsillar pathology
- •Recurrent otitis
- •Sinusitis
- •Respiratory allergy
- •Acute or chronic intestinal disease with diarrhea and/or malabsorption syndrome
- •Lactose intolerance
- •Functional or organic constipation
- •Down syndrome
- •Congenital or acquired heart disease
- •Cerebral palsy
- •Any chronic hepatic, renal, metabolic, or immune system disease
研究组 & 干预措施
Placebo
1 g of rice maltodextrin will be reconstituted in 25-50 ml of tepid water or juice and immediately fed once a day for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.
干预措施: Placebo (Dietary Supplement)
Probiotic
powder of L. acidophilus DDS-1, B. lactis UABLA-12, 50 mg of fructooligosaccharide
1 g of probiotic will be reconstituted in 25-50 ml tepid water or juice and immediately fed once a day (5 billion CFU/daily) for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.
干预措施: L. acidophilus DDS-1, B. lactis UABLA-12 (Dietary Supplement)
结局指标
主要结局
Incidence of respiratory tract infection episodes in a child
时间窗: 1 month
An episode will be defined as display of fever, cough, rhinitis, and sore throat or combination thereof for longer than 48 hours
次要结局
- Duration of respiratory tract infection(21 days)
- Number of workdays missed by parents(21 days)
- Antibiotic prescriptions(21 days)
- Number of unscheduled doctor visits(21 days)
- Number of days daycare/school missed(21 days)
- Time to resolution of individual CARIFS item(21)
- Percent and duration of the use of over-the-counter medications(21day)
- Complications of respiratory tract infections(21 days)
- 25% and 50% decrease in the CARIFS score(21day)
- Severity of respiratory tract infection(21 days)
- Hospitalization rate(21 days)
研究者
Sergei V. Gerasimov, MD, PhD
Associate Professor of Pediatrics
Lviv National Medical University