Beneficial effects of a compound probiotic in Helicobacter pylori-infected patients aged over 40 years: An open-label randomised clinical trial

BACKGROUND: Bismuth quadruple therapy (BQT) is a recommended first-line regimen for Helicobacter pylori (H. pylori) eradication., but its use is limited by side effects and restricted bismuth availability. Probiotic represents an investigational alternative strategy. This study compared the efficacy and safety of triple therapy plus probiotics (TTP)with BQT. METHODS: C-urea breath test ≥28 d after treatment completion. Secondary endpoints included adverse events and adherence. RESULTS: The eradication rates for TTP vs. BQT were 76.4% (126/165) and 86.6% (142/164) in the intention-to-treat (ITT) analysis (difference, -10.2%; 95% CI: -18.5% to -1.9%; P = 0.521) and 84.0% (126/150) and 94.7% (142/150) in the protocol (PP) analysis (difference, -10.7%; 95% CI: -17.5% to -3.8%, P = 0.576). Among patients aged ≥40 y, eradication rates were comparable between TTP and BQT in both the ITT and PP analysis (91.9% vs. 84.9% and 97.1% vs. 93.8%, P = 0.015 and P = 0.019 for noninferiority, respectively). The incidence of adverse event was lower in the TTP group (17.8% vs. 28.7%; P = 0.029). Furthermore, TTP preserved gut microbiota stability, whereas BQT induced dysbiosis. CONCLUSION: While TTP was inferior to BQT in eradication efficacy, it demonstrated better tolerability and protective effects against gut microbiota dysbiosis. In patients aged ≥40 y, TTP achieved non-inferior eradication rates, suggesting this subgroup may warrant further investigation. TRIAL REGISTRATION NUMBER: ChiCTR2200058491.