Efficacy and safety of probiotics combined with P-CAB-containing dual therapy for Helicobacter pylori eradication: a meta-analysis

Abstract Objective To evaluate the efficacy (eradication rate) and safety (incidence of adverse events) of P-CAB-based dual therapy with adjunctive probiotics versus P-CAB dual therapy alone for Helicobacter pylori (H. pylori) infection via a meta-analysis of published randomized controlled trials (RCTs). Methods Systematic literature retrieval was performed across mainstream electronic databases and the ClinicalTrials.gov clinical trial registry platform up to March 2026. A total of 873 articles were initially identified. After strict screening according to predefined inclusion and exclusion criteria, six eligible RCTs with 1,035 participants were finally included. No artificial intelligence tools were applied in literature searching, screening, or data extraction processes. A random-effects model was adopted for pooled quantitative analysis. Results The H. pylori eradication rate in the probiotics combined with dual therapy group was comparable to that in the dual therapy alone group, with no statistically significant difference (RR = 1.012, 95% CI: 0.952–1.076, *p*= 0.702). The overall incidence of adverse events was significantly lower in the experimental group than in the control group (RR = 0.605, 95% CI: 0.431–0.851, *p*=0.0039). Notably, all included studies enrolled only East Asian populations, with limited sample quantity and inconsistent probiotic regimens across trials. Conclusion Probiotic supplementation fails to further improve the eradication efficacy of P-CAB-containing dual therapy but effectively optimizes treatment safety and tolerability. Current findings are limited by single-ethnicity study populations, insufficient included trials, and undefined optimal probiotic strains, dosages, and administration courses. Further high-quality, multi-regional RCTs are required to validate the clinical generalization of this adjuvant strategy.