drugset / Trial / NCT01372943

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

NCT01372943 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-01
Primary completion
2017-01
Completion
2018-08-31

Outcome

Outcome not reported

Stopped: “Research priorities and focus have shifted”

Drugs

EvaluationDrugModalityDoseRoute
Subject synthetic stool Unknown — Other