Tegoprazan dual and quadruple therapy for Helicobacter pylori eradication: a prospective, randomized controlled trial in Beijing, China

Objective The identification of novel and effective treatments for Helicobacter pylori (H. pylori) infection remains a critical need. Treatment is indicated for peptic ulcer disease, gastric MALT lymphoma, and gastric cancer prevention, following diagnosis via non-invasive testing or endoscopy. This study aimed to investigate the efficacy and safety of tegoprazan-based regimens compared to bismuth-containing quadruple therapy in H. pylori eradication. Patients and methods In a randomized, controlled, treatment-naïve adult patients with confirmed H. pylori infection were assigned in a 1:1:1 ratio to one of the following 14-day open-label therapies: BQT (rabeprazole 10 mg twice daily, compound bismuth aluminate granules 2.6 g thrice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily), tegoprazan-based therapies (TAD, tegoprazan 50 mg twice daily, amoxicillin 1 g thrice daily; TBQT, tegoprazan 50 mg twice daily, compound bismuth aluminate granules 2.6 g thrice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily). The primary outcome was the eradication rate of H. pylori. Secondary outcomes included the assessment of adverse events and treatment compliance. Results A total of 468 patients were enrolled. The eradication rates for TBQT, TAD and BQT were 86.3, 85.5 and 77.2%, respectively, by intention-to-treat analysis (p = 0.059), and 87.3, 87.2 and 77.7%, respectively, by per-protocol analysis (p = 0.029). The incidence of adverse events was comparable between the BQT and tegoprazan-based therapies (p > 0.05). Treatment compliance was similar across all three groups. Conclusion Tegoprazan-based therapies achieved acceptable H. pylori eradication rates exceeding 85%, outperforming the BQT. Additionally, tegoprazan-amoxicillin dual therapy may serve as an alternative H. pylori eradication regimen in regions with high clarithromycin resistance. Clinical trial registration http://clinicaltrials.gov , Identifier ChiCTR2300077088.