Effectiveness of Lactobacillus GG in the Prevention of Gastrointestinal and Respiratory Tract Infections in Children With Gastroesophageal Reflux Disease Treated With Proton Pump Inhibitors: Randomized Double - Blind Placebo, Controlled Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Respiratory tract infections
研究概览
简要总结
Background: Proton pump inhibitors (PPI) are effective for treating gastroesophageal reflux disease (GERD). However, they may be associated with an increased risk of gastrointestinal and respiratory tract infections.
Aim: To determine if Lactobacillus GG (LGG) is an effective adjunct to PPI for reducing the risk of gastrointestinal and respiratory tract infections in children with GERD.
Study design: Randomized, double-blind, placebo controlled trial.
详细描述
Patients with GERD treated with PPI will be randomly assigned to receive LGG in dose of 10(9) Colony Forming Units (CFU) twice daily for 6 weeks or a comparable placebo twice daily for 6 weeks.
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
- 1 Month 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical symptoms of GERD
- •treatment with proton pump inhibitors
- •signed informed consent
排除标准
- •treatment with PPI within the last 4 weeks for at least 2 weeks
- •administration of probiotics within 7 days prior to the study
- •acute or chronic respiratory tract infections
- •acute or chronic gastrointestinal tract infections
- •neurological disorders
- •immunodeficiency
结局指标
主要结局
Respiratory tract infections
时间窗: up to 3 months after termination of intervention
Number of upper and lower respiratory tract infections during intervention plus 3 months after termination of the intervention
Gastrointestinal tract infections
时间窗: up to 3 months after termination of intervention
Number of gastrointestinal tract infections during during intervention plus 3 months after termination of the intervention
次要结局
- Number of pneumonias(up to 3 months after termination of intervention)
- Adverse events(up to 3 months after termination of intervention)
研究者
Hanna Szajewska
Professor
Medical University of Warsaw