Efficacy & Cost-Effectiveness of Lactobacillus Reuteri DSM 17938 Administration to Prevent the Risk of Respiratory or Gastrointestinal Infections in Child Day Care Centers: A Randomized, Double Blind, Placebo Control Trial (RDDCT).
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 269
- 主要终点
- days with diarrhoea
研究概览
简要总结
Randomized, doble blind, clinical, controlled trial aimed to investigate the role of Lactobacillus reuteri DSM 17938 in the prevention of gastrointestinal and respiratory tract infections in mexican children who attend day care centers.
Primary Outcome: The primary outcome will be "days with diarrhoea". Secondary Outcomes: a) Days with respiratory tract infections (RTI); b) Days of absences from day care centre; c) Days of antibiotic use; d) Days of medical office visits or emergency visits; and e) Direct and Indirect costs.
Methods: Prospective, randomized, double blind, placebo controlled trial to realize in 260 healthy term infants, born at term (≥36 weeks of gestation), 6 to 36 months old, who will be recruit from Child Care Centers in Mexico and randomly allocated to receive either 1 x 108 colony-forming units of Lactobacillus reuteri DSM 17938 or placebo, each day for 12 weeks, follow up for other additionally 12 weeks of observation. Days with respiratory tract infections (RTI); days of absences from day care centre; days of antibiotic use; days of medical office visits or emergency visits; and direct and Indirect costs will be compare between groups using bi-variate, multiple lineal regression analysis and cost-effectiveness analysis
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
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants
- •Born at term (≥36 weeks of gestation)
- •Any gender
- •6 to 36 months old
- •Same socioeconomic background
- •Written informed consent from parents or legal guardians
排除标准
- •Birth weight <2500 g
- •Congenital anomalies
- •Chronic diseases
- •Failure to thrive
- •Allergy or atopic disease
- •Recent (within the preceding 4 weeks) exposure to probiotics, prebiotics, or antibiotics.
- •Concurrent participation in other clinical trials
结局指标
主要结局
days with diarrhoea
时间窗: January 2011 to June 2011
Diarrhoea is defined as 3 or more loose or watery stools within 24 hours with or without vomiting. Days with diarrhoea is defined as the total amount of days with diarrhoea since the beginning of the study products administration until the last visit occurs. If liquid or loose stools is present a notification shall be made to the principal investigator.
次要结局
- Days with respiratory tract infections (RTI)(January 2011 to June 2011)
- Days of absences from day care centre(January 2011 to June 2011)
- Days of antibiotic use(January 2011 to June 2011)
- Direct and Indirect costs(January 2011 to June 2011)
- Days of medical office visits or emergency visits(January 2011 to June 2011)