Abstract

Fecal microbiota transplantation (FMT) has been shown in numerous case series to be a rapidly acting (within hours to weeks), safe (no serious adverse effects definitely attributed to FMT), and highly effective (worldwide average success rate, 91%) therapy for recurrent Clostridium difficile infection (CDI), even when all other treatments have failed. At present, there remain only 2 impediments to its wide-scale acceptance into the anti-CDI armamentarium. The first is the lack of a randomized controlled trial to prove its effectiveness against a valid comparator. Two current studies will be of value in this regard. The first, the so-called FECAL (Fecal therapy to Eliminate Clostridium difficile Associated Longstanding diarrhoea) trial, has already been completed, and its results are eagerly awaited. In this 3-armed study by Van Nood and colleagues from Amsterdam [1], vancomycin alone (group 1) or with colon lavage (group 2) was compared with nasoduodenal tube administration of FMT after vancomycin and colon lavage (group 3). The second study, whose principal investigators are Colleen Kelly and myself, was recently approved by the National Institutes of Health. This study has a randomized, controlled, blinded design: FMT with either donor stool or patient (recipient) stool (placebo) is used to treat patients with ≥3 recurrences of CDI; failure to respond to treatment will enable the recipient to subsequently receive donor stool in an open fashion. The second impediment to acceptance of FMT, which seems more common in physicians than in patients, is the “yuck” factor. In a prior questionnaire-type study, using data generated by 5 academic physician practices in disparate areas across the United States from patients who had undergone FMT for recurrent CDI and were followed up for ≥3 months, 2 major conclusions were reached. First, 91% of patients were cured by the first FMT, and 98% were either cured by a second FMT or responded to vancomycin, which they had not responded to before FMT. Second, 73% of patients said they would undergo FMT again, and 53% said they would opt to undergo FMT as initial therapy for a future CDI episode [2]. The present study by Zipursky and

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