Survival benefit and safety evaluation of probiotic supplementation in omicron‐infected patients: Real‐world evidence from a multicenter 12,615‐patient cohort

Abstract Gut microbiota dysbiosis has been closely associated with COVID‐19 progression, and probiotic supplementation has been regarded as a potential adjuvant therapy for COVID‐19. However, large‐scale clinical evidence regarding the efficacy of probiotics against the currently predominant Omicron variant remains scarce. This multicenter retrospective cohort study employed a 1:2 propensity score‐matched analysis of hospitalized Omicron‐infected patients from 10 hospitals in Henan Province (probiotics group: 4205 cases vs. control group: 8410 cases). The primary outcome was all‐cause mortality, and the secondary outcome was the incidence of composite disease progression. The results demonstrated that probiotic supplementation significantly reduced all‐cause mortality by 27% (hazard ratio [HR] = 0.73, 95% confidence interval: 0.654‒0.811), with more pronounced benefits observed in patients not receiving antiviral therapy (HR = 0.67) and those with severe disease (HR = 0.69). However, no significant difference was found in the composite disease progression outcome (HR = 1.05, p = .312). Safety assessment indicated that probiotic supplementation was generally well‐tolerated, although transient fluctuations in serum creatinine levels warranted attention. In conclusion, based on the real‐world evidence from a multicenter Omicron‐infected patients’ cohort, the probiotic supplementation could reduce the all‐cause mortality rate of hospitalized patients infected with Omicron, especially in severe cases and without antiviral treatments cases. This study provides the first large‐scale real‐world data and new microbiome‐modulating strategies against future respiratory viral infections.