Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Resolution of diarrhea
研究概览
简要总结
The host gastrointestinal microbiota is significantly influenced by antibiotic treatment which might favor Clostridium difficile infection (CDI), a frequent cause of community- and hospital-acquired, potentially life-threatening diarrhoea. CDI is followed by recurrence in 19-35% of patients despite adequate first line antimicrobial therapy. Currently there is no standardized therapy of recurrent or refractory CDI, but recent studies show remarkable effects of fecal microbiota transplantation (FMT).
In the current project, we aim to ideally match host and donor for FMT success in recurrent or refractory CDI. We will establish a clinical standard operating protocol for FMT, we will evaluate its safety and efficacy, and the patient acceptance and quality of life before and after FMT. We will analyse persistence of the donor microbiota within the recipient, define predictive clinical recipient and donor factors for FMT success and correlate them with microbial host and donor metagenomics.
We hypothesize that our work will yield novel, individualized strategies for recurrent or refractory CDI. In perspective, our results may be expanded to treatment of other inflammory bowel diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •recurrent or refractory CDI
- •previous antimicrobial therapy includes at least on course of vancomycin 4x125 (or higher doses) for at least 7d
- •CDI, defined as: 3 or more loose bowel movements/d AND (presence of C.diff. toxin in stools or toxin producing C. diff. strain) OR (endoscopic or histologic evidence of pseudomembraneous colitis)
排除标准
- •no informed consent
- •no ability to provide informed consent
- •immune suppression (continuous immune-suppressive drugs; steroids: prednisolone-equivalent > 20 mg for 14d or longer)
- •lack of appropriate donor
- •pregnancy
研究组 & 干预措施
FMT
FMT
干预措施: FMT (Biological)
Standard
Vancomycin
干预措施: Vancomycin (Drug)
结局指标
主要结局
Resolution of diarrhea
时间窗: 2 weeks
Resolution of diarrhea
次要结局
- Patient acceptance(2 weeks)
研究者
Martin Goetz
Univ.-Prof. Dr. med. Martin Goetz
University Hospital Tuebingen
