Reduction of C-Difficile Infection Using Fecal Microbiota Transplant
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Negative c-difficile test
研究概览
简要总结
Clostridium-difficile (C-difficile) is a gram positive anaerobic spore-forming bacterium that can lead to severe diarrhea and pseudomembranous colitis. According to Schroeder (2005), there are approximately 3 million cases annually with a mortality rate of 1-2.5 %. It is most often associated with overuse of antibiotics. According to Bartlett & Gerding (2008), 15-25% of anti-microbial-associated diarrhea is caused by C-difficile.
The purpose of this study is to determine if donor fecal microbiota transplant via colonoscopy reduces refractory C-difficile infection better than current routine methods such as continued antibiotic treatment. Specifically, we hypothesize that fecal microbiota transplant via colonoscopy will result in a higher C-difficile cure rate in affected patients versus care as usual in a retrospective cohort.
详细描述
Background
Clostridium-difficile (C-difficile) is a gram positive anaerobic spore-forming bacterium that can lead to severe diarrhea and pseudomembranous colitis. According to Schroeder (2005), there are approximately 3 million cases annually with a mortality rate of 1-2.5 %. It is most often associated with overuse of antibiotics. According to Bartlett & Gerding (2008), 15-25% of anti-microbial-associated diarrhea is caused by C-difficile.
The purpose of this study is to determine if donor fecal microbiota transplant via colonoscopy reduces refractory C-difficile infection better than current routine methods such as continued antibiotic treatment. Specifically, we hypothesize that fecal microbiota transplant via colonoscopy will result in a higher C-difficile cure rate in affected patients versus care as usual in a retrospective cohort.
Current concerns with C-difficile
An increase in C-difficile exposure in hospital settings, especially for immune compromised patients has been noted. The long life of C-difficile spores with poor ability for cleaning agents to kill the spores is a particular concern for patients in critical care and oncology units. In addition, although C-difficile has been considered a hospital acquired disease, there has been an increase in community acquired C-difficile infection with the last few years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18 years of age or older
- •Patient must have a positive C. difficile test within the 10 days prior to the procedure
- •Continued symptoms of c-difficile infection
- •Patients must have failed at least two courses of appropriate antibiotic therapy for C. diff to be a candidate for this procedure
排除标准
- •Under 18 years of age
- •Negative C. difficile test within the 10 days prior to the procedure
- •No symptoms of c-difficile infection
- •Less than two courses of appropriate antibiotic therapy for C. difficile infection
结局指标
主要结局
Negative c-difficile test
时间窗: 30 days
Enrolled patients will test negative for c-difficile following application of the study intervention
次要结局
- Relief of symptoms(30 days)
研究者
Sherri Mendelson
Director Nursing Research and Magnet Program
Providence Holy Cross Medical Center