NCT01372943

Harnessing the Healthy Gut Microbiota to Cure Patients With Recurrent C. Difficile Infection

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Queen's University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
BIOLOGICAL	"synthetic stool" or pure cultures of probiotic intestinal bacteria	"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

Timeline

• Start date: 2010-01-01
• Primary completion: 2017-01-01
• Completion: 2018-08-31
• First posted: 2011-06-14
• Last updated: 2018-11-19

Locations

1 site across 1 country: Canada