Fecal Microbiota Transplantation for the Treatment of Difficult C. difficile Infection Cases

The use of fecal microbiota transplantation (FMT) can aid in the treatment of severe or recurring Clostridium difficile infection cases, said Lawrence J. Brandt, MD, professor of medicine and surgery, Montefiore Medical Center, New York.

Brandt presented treatment strategies for C. difficile during the “Clinical Practice Skills in a Changing World” session at the 2014 American Gastroentrological Association Clinical Congress of Gastroentrology and Hepatology in Miami Beach, FL, on Jan 17.

The rate of C. difficile infection has been increasing and is associated with nearly $5 billion in excess health care costs annually in the US. Although gastroenterologists can now refer to the American College of Gastroenterology’s “Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections,” published last year, there has otherwise been no treatment algorithm readily accepted by gastroenterologists, Brandt said.

As clinicians consider how to treat mild, moderate, severe, or complicated cases of C. difficile infection, they must work their way through various medical options, such as metronidazole the therapy of choice for mild to moderate disease, according to the ACG guidelines), vancomycin (for severe cases and in cases of a second relapse), fidaxomicin (especially in patients who are refractory or resistant to vancomycin), and monoclonal antibodies, Brandt said. When C. difficile cases become severe or complicated, surgery is another option.

Fifteen to twenty percent of patients who have experienced C. difficile before will have a relapse, said Brandt. The more often the patient experiences an episode of C. difficile infection, the more likely that there will be additional recurrences. “I’ve had several patients with recurrences over 9, 10, and 11 years,” he said. Certain patients may be more likely to have recurrences due to impaired host response or to decreased diversity in their fecal microbiome.

Fecal Transplants

With FMT, patients can avoid prolonged, repeated courses of antibiotics. The procedure can also help to re-establish normal intestinal microbiome diversity, assisting patients in restoring colonization resistance, Brandt said.

During FMT, clinicians use stool from a prescreened healthy donor. The donor must not have used any antibiotics within three months and not have any diseases or conditions thought to upset the microbiome, included cancer, obesity, and mood disorders, as well as a variety of gastrointestinal diseases. The recipient receives an enema with the extracted stool from a donor suspended in a solution and retains the enema for several hours.

A 2013 study from van Nood et al. published in the New England Journal of Medicine found an 81.3% cure rate with nasoduodenal FMT. A 2012 study authored by Brandt and colleagues found that 97% of patients who had FMT would use the therapy again if necessary.

Physicians are also starting to view FMT for the treatment of recurrent C. difficile infection more favorably, Brandt said. Additionally, the FDA backed down on a decision last year that designated stool for transplant as a biologic drug (which would have required any clinicians who wanted to perform FMT to have an IND permit). The FDA changed its perspective and said that it is OK to use so long as the patient has not responded to traditional treatment and that clinicians tell patients the treatment is investigational.

Remaining concerns about FMT include acute infections and acute allergic reactions, Brandt said. Going forward, FMT may be used to treat other diseases, he added.