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临床试验/NCT01942447
NCT01942447Unknown不适用

Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis

University Hospital Tuebingen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

FMT

干预措施: FMT (Biological)

Standard

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Goetz

Univ.-Prof. Dr. med. Martin Goetz

University Hospital Tuebingen

研究点 (1)

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