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World J Gastroenterol. Oct 7, 2026; 32(37): 119668
Published online Oct 7, 2026. doi: 10.3748/wjg.119668
Efficacy of 7-day and 14-day potassium-competitive acid blocker-based bismuth-containing quadruple regimen for Helicobacter pylori infection
Chang Kyo Oh, Hyun Lim, Jin Hee Noh, Eun Jeong Gong, Seung In Seo, Chang Seok Bang, Yu Jin Kim, Woon Geon Shin, Jin Bae Kim, Hyun Joo Jang, Gwang Ho Baik
Chang Kyo Oh, Yu Jin Kim, Jin Bae Kim, Department of Gastroenterology, Gangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul 07441, South Korea
Chang Kyo Oh, Hyun Lim, Jin Hee Noh, Eun Jeong Gong, Seung In Seo, Chang Seok Bang, Yu Jin Kim, Woon Geon Shin, Jin Bae Kim, Hyun Joo Jang, Gwang Ho Baik, Institute for Liver and Digestive Diseases, Hallym University, Chuncheon 24252, Gangwon-do, South Korea
Hyun Lim, Jin Hee Noh, Department of Gastroenterology, Hallym University College of Medicine, Hallym University Sacred Heart Hospital, Anyang 14068, South Korea
Eun Jeong Gong, Chang Seok Bang, Gwang Ho Baik, Department of Gastroenterology, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon 24253, Gangwon-do, South Korea
Seung In Seo, Woon Geon Shin, Department of Gastroenterology, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul 05355, South Korea
Hyun Joo Jang, Department of Gastroenterology, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong 18450, Gyeonggi-do, South Korea
Author contributions: Oh CK conceived the idea presented in this study; Lim H revised the study design, created the statistical settings for this study; Noh JH, Gong EJ, Seo SI, Bang CS, Kim YJ, Shin WG, Kim JB, Jang HJ, and Baik GH developed the theory; all authors discussed the results, read and approved the final manuscript.
Supported by HK inno.N, Republic of Korea, No. KCAB_017.
Institutional review board statement: The protocol was approved by the Ministry of Food and Drug Safety in Korea and the Institutional Review Board (approval no. 2021-09-013-001).
Clinical trial registration statement: This study adhered to the CONSORT guidelines and was registered with the International Clinical Trials Registry Platform (KCT0007444) in June 2022.
Informed consent statement: All participants provided informed consent.
Conflict-of-interest statement: All authors declare no conflict of interest in publishing the manuscript.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: The data that support the findings of this study are available from the corresponding author upon reasonable request. The data are not publicly accessible because of information that could compromise the privacy or consent of research participants.
Corresponding author: Hyun Lim, MD, PhD, Department of Gastroenterology, Hallym University College of Medicine, Hallym University Sacred Heart Hospital, 22 Gwanpyeong-Ro 170-Gil, Dongan-Gu, Anyang 14068, South Korea.
hlim77@hallym.or.kr
Received: February 3, 2026
Revised: March 17, 2026
Accepted: May 27, 2026
Published online: October 7, 2026
Processing time: 210 Days and 20.5 Hours
BACKGROUND
Potassium-competitive acid blocker-based regimens may offer advantages over proton pump inhibitor-based regimens for Helicobacter pylori (H. pylori) eradication by suppressing gastric acid secretion more strongly and rapidly.
AIM
To compare the effectiveness and tolerability of 7-day and 14-day potassium-competitive acid blocker-based bismuth-containing quadruple regimen (PC-BMT) against a 14-day proton pump inhibitor-based bismuth-containing quadruple regimen (P-BMT) in settings with ≥ 15% clarithromycin resistance.
METHODS
Treatment-naïve H. pylori patients were assigned in a random one of three groups: (1) 7-day PC-BMT (tegoprazan 50 mg twice daily, bismuth 120 mg four times daily, metronidazole 500 mg three times daily, and tetracycline 500 mg four times daily); (2) 14-day PC-BMT; and (3) 14-day P-BMT. Compliance, eradication rates, and treatment-related adverse events were evaluated across the three groups.
RESULTS
The intention-to-treat (ITT) analysis included 119 patients, 118 patients, and 117 patients in the 7-day PC-BMT, 14-day PC-BMT, and 14-day P-BMT groups, respectively. In the modified ITT population, eradication rates were 80.5%, 83.8%, and 80.5%, and the per-protocol rates were 81.7%, 87.5%, and 79.3%, respectively. The 14-day PC-BMT was non-inferior to the 14-day P-BMT in modified ITT and per-protocol analyses but not in the ITT analysis. The 7-day PC-BMT regimen was not non-inferior to the 14-day P-BMT regimen. Treatment-related adverse events occurred in 19.3%, 29.7%, and 26.5% of patients, with no serious events and no significant between-group differences. Compliance exceeded 95% across all regimens.
CONCLUSION
The 14-day PC-BMT regimen demonstrated non-inferior efficacy, acceptable safety, and high compliance compared with the 14-day P-BMT regimen, suggesting it may serve as a viable treatment option for H. pylori eradication when clarithromycin resistance is ≥ 15%.
Core Tip: Bismuth-containing quadruple therapy is recommended as first-line treatment for Helicobacter pylori in regions with high clarithromycin resistance, yet the optimal acid suppressant and treatment duration remain unclear. This multicenter randomized trial is the study to evaluate tegoprazan, a potassium-competitive acid blocker, within a bismuth-metronidazole-tetracycline quadruple regimen. The 14-day tegoprazan-based regimen achieved non-inferior eradication compared with the conventional 14-day proton pump inhibitor-based regimen, whereas the 7-day regimen did not. These results highlight that tegoprazan-based bismuth quadruple therapy requires a 14-day duration to ensure adequate eradication efficacy.
