Probiotics for Clostridium difficile infection in adults (PICO): Study protocol
for a double-blind, randomized controlled trial.
Author(s): Barker A(1), Duster M(2), Valentine S(3), Archbald-Pannone L(4), Guerrant R(5),
Safdar N(6).
Affiliation(s): Author information:
(1)University of Wisconsin School of Medicine and Public Health, Department of
Population Health Sciences, Madison, WI, USA. Electronic address:
akbarker@wisc.edu. (2)University of Wisconsin, Madison, WI, USA. Electronic
address: mnd@medicine.wisc.edu. (3)Department of Medicine, University of
Wisconsin Hospital, Madison, WI, USA. Electronic address:
svalentine@medicine.wisc.edu. (4)University of Virginia, School of Medicine,
Department of Medicine, Division of General, Geriatric, Palliative, and Hospital
Medicine, Charlottesville, VA, USA; University of Virginia, School of Medicine,
Department of Medicine, Division of Infectious Diseases and International Health,
Charlottesville, VA, USA. Electronic address: LA2E@hscmail.mcc.virginia.edu.
(5)University of Virginia, School of Medicine, Department of Medicine, Division
of Infectious Diseases and International Health, Charlottesville, VA, USA.
Electronic address: rlg9a@virginia.edu. (6)Division of Infectious Diseases,
Department of Medicine, University of Wisconsin Hospital, Madison, WI, USA;
William S. Middleton Memorial Veterans Affairs Hospital, Madison, WI, USA;
Department of Infection Control, University of Wisconsin Hospital and Clinics,
Madison, WI, USA. Electronic address: ns2@medicine.wisc.edu.
Publication date & source: 2015, Contemp Clin Trials. ,
BACKGROUND: Clostridium difficile is a pathogen of rapidly increasing public
health importance. An estimated quarter of a million Clostridium difficile
infections (CDI) occur in the United States annually, at a resultant cost of
14,000 deaths and 1 billion dollars. Clostridium difficile related deaths have
risen 400% over the last decade, and current standard antibiotic treatments are
only 75 to 85% successful. Besides increasing the risk of antibiotic resistance
and side effects, these treatments are very expensive. The most vulnerable
population for Clostridium difficile is older adults, who make up approximately
half of the cases, but account for 90% of the related deaths. Probiotics may have
potential as adjunctive therapeutic agents for CDIs, however, current data is
limited.
METHODS: This pilot study is a single-site, randomized, placebo-controlled,
double-blind, phase two clinical trial. The trial primarily evaluates the effect
of four weeks of probiotic therapy in addition to standard of care on Clostridium
difficile diarrhea duration and recurrence. Secondary outcomes include effect on
fecal cytokines, fecal lactoferrin, and Clostridium difficile toxin density in
stool, as well as patient functional status.
DISCUSSION: This pilot study will determine the feasibility and effect size to
conduct larger randomized controlled trials of probiotic interventions in
patients with CDI, to determine the impact of probiotics on the symptoms of CDI.
ClinicalTrials.gov Identifier: NCT01680874.
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