6/29/23, 1:37 AM PLACIDE Pathway Feedback Search Clinical Topics Home Studies PLACIDE PLACIDE Disease Clostridioides difficile infection 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 N = 17420 47.1% male 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) https://web.pathway.md/studies/recVxW6rNqtnnW56P 1/2 6/29/23, 1:37 AM PLACIDE Pathway Primary outcome Antibiotic-associated diarrhea 10.8 % 10.8 10.4 8.1 % 5.4 % 2.7 % No significant difference 0.0 % Microbial preparation Placebo 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. Open reference URL https://web.pathway.md/studies/recVxW6rNqtnnW56P 2/2