Presenter: Mark Mellow, MD, (INTERGRIS Baptist Medical Center in Oklahoma)
ACG Plenary Session—Original Research: 2011 ACG Governors Award Recipient for Excellence in Clinical Research
Clostridium difficile infection is a serious, life-threatening nosocomial infection that can follow on the heels of broad-spectrum antibiotic use. It affects over 500,000 Americans annually, with 15,000 deaths. Infection recurs in 15% to 25% of those initially treated successfully; infection subsequently redevelops in 40% to 50% of those an initial recurrence.
The standard of care for the infection is metronidazole and/or vancomycin, but many patients with initial C difficile infection experience recurrent infection despite multiple courses of antibiotic treatment. Alternative therapies, including probiotic approaches, are currently under study given the relative ineffectiveness of antibiotics—in this case, using donor stool in liquid suspension to re-populate the colon of patients with C difficile with non-pathogenic bacteria.
Dr. Mellow presented the results of a five-center/five-state retrospective review and survey of 77 adult patients who had previously failed multiple courses of antibiotics for C difficile colitis before receiving fecal microbiota transplant (FMT). FMT was first tried in 1958, and a number of widely-reported recent studies have lent support to this probiotic approach. By re-establishing healthy fecal bacterial diversity, FMT may represent a safe and effective modality for treating C difficile infection. The subject population was an average age of 65 years; this was primarily a chronically-ill elderly population (56 women, 21 men). At the time of analysis, 31 were either hospitalized, in a skilled nursing facility, or were house-bound. All subjects had FMT at least 3 months before the review; the longest-studied had FMT nearly 5 years before (mean was 17 months). The average duration of C difficile infection before FMT was 11 months’for most of these people, chronic diarrhea with severe fatigue and weight loss (mean = 20 pounds) had become a permanent part of their lives.
FMT resulted in cure for 70 out of 77 patients (91% primary cure). In 6 of the remaining 7 patients, a single two-week course of vancomycin plus one additional FMT resulted in cure (98% secondary cure). Diarrhea resolved within one week for most patients (mean = 6 days). A total of 30 patients subsequently required antibiotics for an unrelated infection; of those, C difficile recurred in 8. C difficile infection did not recur in a single patient given antibiotics.
In this study, most donors were spouses, family members, or friends. One patient was treated with unknown donor stool, which raises questions about safety. There is potential for transmission of hepatitis, HIV, and other infections. But in the setting of a donor already sexually intimate with the patient, FMT represents a huge opportunity for further study, hopefully with sham randomization. This treatment becomes the standard of care for C difficile infection.
Although most centers administer the stool via colonoscope, there is no current evidence to favor this approach over enema. Administration by enema would radically decrease cost for the treatment and contribute to the procedure&38217;s adoption—this could become a primary care procedure. Fifty-three percent of patients reported that they would have chosen FMT as primary treatment if given the choice. If we weren’t talking about using someone else’s stool as therapy, one guesses it would have been higher!