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

Triple therapy plus probiotics (TTP) had lower overall H. pylori eradication rates compared to bismuth quadruple therapy (BQT) in both ITT and PP analyses.

• ITT eradication rates: TTP 76.4% (126/165) vs. BQT 86.6% (142/164); difference -10.2%; 95% CI: -18.5% to -1.9%
• PP eradication rates: TTP 84.0% (126/150) vs. BQT 94.7% (142/150); difference -10.7%; 95% CI: -17.5% to -3.8%
• P = 0.521 for ITT and P = 0.576 for PP analyses
• Both regimens were administered for 14 days and included amoxicillin, clarithromycin, and esomeprazole; TTP replaced bismuth potassium citrate with a compound probiotic
• Eradication was confirmed by 13C-urea breath test ≥28 days after treatment completion

In patients aged ≥40 years, TTP achieved non-inferior eradication rates compared to BQT.

• ITT eradication rates in patients aged ≥40 years: TTP 91.9% vs. BQT 84.9%; P = 0.015 for noninferiority
• PP eradication rates in patients aged ≥40 years: TTP 97.1% vs. BQT 93.8%; P = 0.019 for noninferiority
• This subgroup analysis suggests patients aged ≥40 years may warrant further investigation for TTP use

The incidence of adverse events was significantly lower in the TTP group compared to the BQT group.

• Adverse event incidence: TTP 17.8% vs. BQT 28.7%; P = 0.029
• This finding supports better tolerability of TTP over BQT
• Adverse events and adherence were assessed as secondary endpoints

TTP preserved gut microbiota stability, whereas BQT induced gut microbiota dysbiosis.

• BQT treatment was associated with dysbiosis of the gut microbiota
• TTP had protective effects against gut microbiota dysbiosis
• Gut microbiota analysis was conducted as part of the secondary endpoint assessments
• This difference represents a potential advantage of probiotic-containing regimens over bismuth-based therapy

Bismuth quadruple therapy is a recommended first-line regimen for H. pylori eradication but its use is limited by side effects and restricted bismuth availability.

• BQT consists of bismuth potassium citrate, amoxicillin, clarithromycin, and esomeprazole
• Probiotics are described as an 'investigational alternative strategy' to bismuth in H. pylori eradication
• The study was registered under ChiCTR2200058491
• The trial was designed as an open-label randomised clinical trial