PLACIDE
Trial question
What is the role of multistrain preparation of lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhea and C. difficile diarrhea in older patients?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
52.9% female
47.1% male
N = 17420
17420 patients (1485 female, 1456 male)
Inclusion criteria: inpatients ≥ 65 years of age and exposed to ≥ 1 oral or parenteral antibiotics
Key exclusion criteria: existing diarrhea, immunocompromised, active IBD, suspected acute pancreatitis, illness needing high dependency or intensive care, prosthetic heart valve, CDD in the previous 3 months
Interventions
N=1493 microbial preparation (multistrain preparation of lactobacilli and bifidobacteria, with a total of 6 × 10(10) organisms, one capsule per day for 21 days)
N=1488 placebo (identical placebo, one capsule per day for 21 days)
Primary outcome
Antibiotic-associated diarrhea
10.8
10.4
10.8 %
8.1 %
5.4 %
2.7 %
0.0 %
Microbial
preparation
Placebo
No significant
difference ↔
No significant difference in antibiotic-associated diarrhea (10.8% vs. 10.4%; RR 1.04, 95% CI 0.84 to 1.28)
Secondary outcomes
No significant difference in C. difficile diarrhea (0.8% vs. 1.2%; RR 0.71, 95% CI 0.34 to 1.47)
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In inpatients ≥ 65 years of age and exposed to ≥ 1 oral or parenteral antibiotics, microbial preparation was not superior to placebo with respect to a antibiotic-associated diarrhea.
Reference
Allen SJ, Wareham K, Wang D et al. Lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea and Clostridium difficile diarrhoea in older inpatients (PLACIDE): a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2013 Oct 12;382(9900):1249-57.
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