Effect of Fecal Microbiota Transplantation on Recurrence in Multiply Recurrent Clostridium difficile Infection
Abstract
Clostridium difficile infection (CDI) is the most common health careassociated infection in U.S. hospitals, with approximately 453000 infections and 29000 deaths in 2011 (1). Antibiotics are frequently ineffective (2, 3), with recurrence rates of 15% to 35% after a first episode and up to 65% after treatment of a second recurrence (4, 5). Recurrences are clinically challenging and are typically treated with prolonged courses of antibiotics, which maintain and exacerbate intestinal dysbiosis (6). Fecal microbiota transplantation (FMT) restores the normal composition of gut microbiota and is recommended when antibiotics fail to clear the infection (3). However, the evidence for FMT rests largely on case series and several open-label clinical trials that have suggested cure rates of 81% to 100% in recurrent CDI (712). To date, there has not been an adequately controlled and blinded trial of FMT for CDI treatment. Furthermore, the optimal method for administering FMT has not been determined. Evidence suggests that colonoscopic delivery has advantages in terms of efficacy (9), safety (13), and patient acceptance and tolerability (14) compared with administration via the nasoenteric route. We therefore performed a double-blind, randomized, controlled study of colonoscopic FMT for treatment of recurrent CDI. Cure rates and adverse events (AEs) were compared between donor FMT and autologous FMT (given as a placebo) in patients who had at least 3 CDI recurrences. Methods Design…
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