Tegoprazan-based dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori eradication: a prospective, multicenter, open-label, non-inferiority, randomized controlled trial.

Background Current standard therapies for Helicobacter pylori (H. pylori) are limited by side effects and antibiotic resistance. Evidence suggests that high-dose amoxicillin dual therapy with a proton pump inhibitor offers comparable efficacy with an improved safety profile. Methods This trial substituted the novel acid blocker tegoprazan for a proton pump inhibitor in the dual therapy regimen. We enrolled 400 patients with confirmed H. pylori infection from the gastroenterology departments of multiple general hospitals in Jiangsu Province between March 2024 and September 2025. Participants were randomly assigned in a 1:1 ratio to a 14-day course of either TA dual therapy (tegoprazan 50 mg twice daily and amoxicillin 1000 mg three times daily) or TBQ quadruple therapy (tegoprazan 50 mg, amoxicillin 1000 mg, furazolidone 100 mg, and colloidal bismuth pectin 300 mg, all twice daily). A 13C- or 14C-urea breath test was performed at least 4 weeks after treatment completion to assess the primary outcome of eradication rate. Secondary outcomes included the incidence of adverse events and medication adherence. Results In the intention-to-treat analysis, eradication rates were 87.5% (95% CI: 82.9 to 92.1%) for the TA group and 89.5% (95% CI: 85.3 to 93.8%) for the TBQ group. Non-inferiority of the TA regimen was established (P = 0.006). Similar results were observed in the modified intention-to-treat (90.7% vs. 94.7%; P = 0.012 for non-inferiority) and per-protocol analyses (90.6% vs. 94.7%; P = 0.012 for non-inferiority). The incidence of adverse reactions in the TA group was lower than that in the TBQ group, at 8.2% and 20.1% respectively, with a statistically significant difference (P < 0.001). There was no statistically significant difference in medication adherence between the two groups of subjects (P = 0.197). Conclusion The efficacy of the tegoprazan dual therapy regimen in eradicating H. pylori was not inferior to that of the tegoprazan quadruple therapy regimen, while also exhibiting a lower incidence of adverse reactions. Adherence to medication was similar between the two groups. These findings suggest that tegoprazan-based dual and quadruple therapies may achieve satisfactory efficacy in eradicating H. pylori. Clinical trial registration: https://clinicaltrials.gov/, identifier NCT06340334. Registered on March 30, 2024.