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J Antimicrob Chemother. 2017 Nov 1;72(11):3177-3180. doi: 10.1093/jac/dkx254.

A randomized controlled trial of probiotics for Clostridium difficile infection in adults (PICO).

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Department of Population Health Sciences, School of Medicine and Public Health, University of Wisconsin, Madison, WI, USA.
Division of Infectious Disease, Department of Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.
Division of General, Geriatric, Palliative and Hospital Medicine, Department of Medicine, School of Medicine, University of Virginia, Charlottesville, VA, USA.
Division of Infectious Diseases and International Health, Department of Medicine, School of Medicine, University of Virginia, Charlottesville, VA, USA.
William S. Middleton Memorial Veterans Affairs Hospital, Madison, WI, USA.
Department of Infection Control, University of Wisconsin Hospital and Clinics, Madison, WI, USA.



Clostridium difficile is the most common cause of hospital-acquired infections, responsible for >450000 infections annually in the USA. Probiotics provide a promising, well-tolerated adjunct therapy to standard C. difficile infection (CDI) treatment regimens, but there is a paucity of data regarding their effectiveness for the treatment of an initial CDI.


We conducted a pilot randomized controlled trial of 33 participants from February 2013 to February 2015 to determine the feasibility and health outcomes of adjunct probiotic use in patients with an initial mild to moderate CDI.


The intervention was a 28 day, once-daily course of a four-strain oral probiotic capsule containing Lactobacillus acidophilus NCFM, Lactobacillus paracasei Lpc-37, Bifidobacterium lactis Bi-07 and B. lactis Bl-04. The control placebo was identical in taste and appearance. Registered at trial registration number = NCT01680874.


Probiotic adjunct therapy was associated with a significant improvement in diarrhoea outcomes. The primary duration of diarrhoea outcome (0.0 versus 1.0 days; P = 0.039) and two exploratory outcomes, total diarrhoea days (3.5 versus 12.0 days; P = 0.005) and rate of diarrhoea (0.1 versus 0.3 days of diarrhoea/stool diary days submitted; P = 0.009), all decreased in participants with probiotic use compared with placebo. There was no significant difference in the rate of CDI recurrence or functional improvement over time between treatment groups.


Probiotics are a promising adjunct therapy for treatment of an initial CDI and should be further explored in a larger randomized controlled trial.

[Indexed for MEDLINE]
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