Results of the Phase 2 PUNCH™ CD Safety Study of RBX2660 (microbiota suspension) for Recurrent C. difficile Infection
Erik Dubberke, MD, MSPH, Washington University School of Medicine, St. Louis, MO; Robert Orenstein, DO, Mayo Clinic Arizona, Phoenix, AZ; Kathleen Mullane, DO, PharmD, University of Chicago Medicine, Chicago, IL; Robert Hardi, MD, Capital Digestive Care, Chevy Chase, MD; Arnab Ray, MD, Ochsner Clinic, New Orleans, LA; Mary Kay Sobcinski, RN, MHA, Rebiotix Inc., Roseville, MN
Clostridium difficile infection (CDI) places an increasingly large burden on healthcare systems worldwide in terms of morbidity, mortality and costs.1,2
Approximately 25% of patients suffer from recurrence of disease, and recurrent CDI is especially challenging to treat.3
There is increasing recognition that fecal microbiota transplantation (FMT) is an effective treatment for recurrent CDI.4-6
A systematic evaluation of the safety of FMT has not been been done; concerns remain.
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Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18 (Suppl 6):21-7.
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Lee CH, Belanger JE, Kassam Z.. The outcome and long-term follow-up of 94 patients with recurrent and refractory Clostridium difficile infection using single to multiple fecal microbiota transplantation via retention enema. Eur J Clin Microbiol Infect Dis. 2014;33(8):1425-8.
Patel NC1, Griesbach CL, DiBaise JK, Orenstein R. Fecal microbiota transplant for recurrent Clostridium difficile infection: Mayo Clinic in Arizona experience. Mayo Clin Proc. 2013 Aug;88(8):799-805.