SPAADA
Trial question
What is the role of high-dose multi-strain probiotic mix for prevention of antibiotic-associated diarrhea in patients receiving broad-spectrum antibiotics?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
62.0% female
38.0% male
N = 555
555 patients (346 female, 209 male).
Inclusion criteria: patients receiving broad-spectrum antibiotics.
Key exclusion criteria: antibiotic use in the past 60 days; daily consumption of probiotics, yogurt with probiotics, and inability to stop the consumption; an episode of diarrhea within 30 days before screening; prior infection of C. difficile ≤ 3 months before screening.
Interventions
N=282 probiotic mix (high-dose multi-strain probiotic mix [Sinquanon®] from the first dose of antibiotics until 14 days after the last antibiotic dose).
N=273 placebo (matching placebo from the first dose of antibiotics until 14 days after the last antibiotic dose).
Primary outcome
Antibiotic-associated diarrhea
9.2%
25.3%
25.3 %
19.0 %
12.7 %
6.3 %
0.0 %
Probiotic
mix
Placebo
Significant
decrease ▼
NNT = 6
Significant decrease in antibiotic-associated diarrhea (9.2% vs. 25.3%; RR 0.36, 95% CI 0.24 to 0.55).
Secondary outcomes
Significant decrease in mild antibiotic-associated diarrhea (8.2% vs. 16.8%; RR 0.49, 95% CI 0.18 to 0.8).
No significant difference in the rate of antibiotic-associated diarrhea ≥ 6 days (11.5% vs. 21.6%; RR 0.53, 95% CI -0.39 to 1.45).
Significant decrease in abdominal pain (18.1% vs. 36.6%; RR 0.49, 95% CI 0.37 to 0.66).
Safety outcomes
No significant difference in adverse events and serious adverse events.
Conclusion
In patients receiving broad-spectrum antibiotics, probiotic mix was superior to placebo with respect to a antibiotic-associated diarrhea.
Reference
Vladimir Hodzhev, Karen Dzhambazov, Nikolay Sapundziev et al. High-dose Probiotic Mix of Lactobacillus spp., Bifidobacterium spp., Bacillus coagulans, and Saccharomyces boulardii to Prevent Antibiotic-associated Diarrhea in Adults: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial (SPAADA). Open Forum Infect Dis. 2024 Oct 21;11(11):ofae615.
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