跳至主要内容
临床试验/NCT01372943
NCT01372943终止不适用

A Study Using "Synthetic Stool" or Pure Cultures of Probiotic Intestinal Bacteria From Healthy Donor Stool That Can be Used as an Enema to Replace the Use of Stool Transplant, for Treatment of Recurrent and Refractory CDI

Queen's University2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2010年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
number of participants cured of CDI

研究概览

简要总结

CDI (Clostridium difficile infection) causes diarrheal illness and can cause colitis which may be fatal. A patient being treated for CDI has a 10-25% chance of developing relapse. Recurrent CDI is on the rise. There are few options available to treat recurrent CDI. "Stool transplant" (infusing donor stool into the intestine of the recipient), is not very palatable to either patient or medical personnel. The investigators will isolate intestinal bacteria from donor stool and use this purified mixture of donor bacteria instead of stool transplant. The investigators hypothesize that this cleaner mixture of purely isolated intestinal bacteria from a healthy donor would be equally effective as conventional fecal bacteriotherapy, which uses donor stool. The use of this prepared mixture of aerobic and anaerobic organisms, or probiotic approach, is based on the same principle of fecal flora reconstitution. However our approach would provide a more controlled, reproducible, cleaner and more aesthetically acceptable method of administration, and from a patient safety perspective, would also be a safer strategy than using freshly defecated donor fecal matter.

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

入选标准

  • patients with recurrent CDI that have failed standard therapy

排除标准

  • critically ill patients

研究组 & 干预措施

synthetic stool

Experimental

"synthetic stool" or pure cultures of probiotic intestinal bacteria from healthy donor stool that can be used as an enema to replace the use of stool transplant, for treatment of recurrent and refractory CDI

干预措施: "synthetic stool" or pure cultures of probiotic intestinal bacteria (Biological)

结局指标

主要结局

number of participants cured of CDI

时间窗: 6 months

次要结局

未报告次要终点

研究者

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

Dr. Mark Ropeleski

Physician

Queen's University

研究点 (2)

Loading locations...

相似试验