CLINICAL TRIAL article
Front. Med.
Sec. Gastroenterology
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1629567
Tegoprazan dual and quadruple therapy for Helicobacter pylori eradication: a prospective, randomized controlled trial in Beijing, China
Provisionally accepted
Jianping Cheng1*
Xiaolin Zhao1Chanjuan Fan1
Kun Huang1Yong Cai1Zhen Li1Dongling Xie1Lili Zhai1
Xiaomei Zhang2Haiou Ding1- 1Civil Aviation General Hospital, Beijing, China
- 2Chinese PLA General Hospital, Beijing, China
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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 evaluated the efficacy and safety of tegoprazanbased regimens, a potassium-competitive acid blocker, compared to standard bismuthcontaining quadruple therapy (BQT) in H. pylori eradication.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 the TBQT, TAD and BQT groups 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 regimens (P > 0.05). Treatment compliance was similar across all three groups.Tegoprazan-based therapies achieved acceptable satisfactory H. pylori eradication rates exceeding 85%, outperforming the standard BQT. Additionally, the tegoprazanamoxicillin dual therapy may serve as an alternative H. pylori eradication regimen in regions with high clarithromycin resistancedemonstrated enhanced cost-effectiveness, presenting a viable alternative for H. pylori eradication.The trial was registered at ClinicalTrials.gov (ChiCTR2300077088) on
Keywords: Helicobacter pylori, Tegoprazan, Bismuth, Dual therapy, Quadruple therapy, Eradication rate
Received: 16 May 2025; Accepted: 31 Jul 2025.
Copyright: © 2025 Cheng, Zhao, Fan, Huang, Cai, Li, Xie, Zhai, Zhang and Ding. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Jianping Cheng, Civil Aviation General Hospital, Beijing, China
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