The Effect of Probiotics on Sputum Bacteria, Sputum Inflammation, and Pulmonary Infections in Patients With Cystic Fibrosis: A Double-blind Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 主要终点
- The effect of probiotics on the rate of pulmonary infections compared to placebo
研究概览
简要总结
Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic treatment. These factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens. A pilot study performed by the researchers using probiotics in CF patients showed a decrease in the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum inflammatory markers in CF patients.
详细描述
Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic treatment. These factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens. A pilot study performed by the researchers using probiotics in CF patients showed a decrease in the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum inflammatory markers in CF patients. The study will be a cross-over study of probiotic and placebo arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cystic fibrosis mild to moderate
- •at least 3 pulmonary exacerbations requiring antibiotics per year
- •Pseudomonas aeruginosa in the sputum
- •able to produce sputum
排除标准
- •severe pulmonary disease
- •less than 3 pulmonary exacerbations per year
- •unable to produce sputum
结局指标
主要结局
The effect of probiotics on the rate of pulmonary infections compared to placebo
时间窗: October 2012
The rate of pulmonary exacerbations requiring IV or PO antibiotic treatment during the study period in the treatment and placebo groups will be assessed.
次要结局
- The effect of probiotics on sputum inflammatory markers(October 2012)
- The effect of probiotics on gastrointestinal inflammation(October 2012)
- The effect of probiotics on sputum bacteria compared to placebo(October 2012)
研究者
Batia Weiss
Director, Pediatric Gastroenterology Unit, Edmond and Lily Safra Children's Hospital
Sheba Medical Center