Fecal transplantation for the treatment of Clostridium difficile-associated disease or ulcerative colitis

IHE STE Report Summary

What

A rapid evidence assessment prepared by the Institute of Health Economics Health Technology Assessment Group. The research focuses on the safety, effectiveness, and cost-effectiveness of fecal transplantation for the treatment of Clostridium difficile-associated disease and/or ulcerative colitis.

When

The report release date is August 2011.

Why

The report was requested by the Government of Alberta to help determine the viability of fecal transplantation as a treatment for specific instances of gastrointestinal illnesses that do not respond to standard care.

Where

The report is available online at STE Fecal Transplantation Report.

Summary

Definitions

Clostridium difficile (C. difficile) is the most important and common nosocomial (acquired as a result of healthcare treatment or through other direct contact with the healthcare system) pathogen of health care-associated diarrhoea in hospitalised patients in developed countries. It causes millions of human infections worldwide annually and mainly affects elderly patients. While more than 90% of patients respond to initial standard antibiotics, 15% to 35% experience a relapse in symptoms after discontinuation of the treatment.

Ulcerative colitis is a chronic and relapsing disease characterised by diffuse mucosal inflammation of the colon. An estimated 88,500 Canadians were living with this disease in 2008, and more than 4,100 new cases are diagnosed annually.

Fecal transplantation, also known as fecal bacteriotherapy, fecal transfusion, or human probiotic infusion, refers to the process of instilling a liquid suspension of stool from a healthy donor into the patient's upper gastrointestinal tract through a nasoduodenal catheter or into the colon through a colonoscope or an enema catheter.

Report Findings

It should be noted that the need for fecal transplantation as an alternative to standard care is required only in a small group of patients whose recurrent C. difficile-associated disease and/or ulcerative colitis failed to respond to standard care. This, along with the procedure's lack of aesthetic appeal, accounts for the few case studies available for review; those that can be found in the literature involve relatively small populations ranging from six to 45 patients. No economic studies were located and the provincial data required to conduct an economic analysis was not found.

The limited evidence of 10 case series studies indicates fecal transplantation-if performed according to a strict protocol by an expert practitioner-may be a safe, low-risk alternative for C. difficile-associated disease and/or ulcerative colitis that prove unresponsive to standard care. In most cases, fecal transplantation recipients stayed diarrhea-free for several months or even years. Few serious adverse events were noted; where they were present, insufficient evidence exists to determine whether the actual fecal transplantation was responsible or whether additional factors were to blame.

More evidence on the use of fecal transplantation in treating recurrent C. difficile-associated disease will be available with the release of information from two randomized control trials. The first, being undertaken in the Netherlands, runs through February 2012; the second, Canadian study, will conclude in December 2013.

Contact

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