Clinical Trials Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 28, 2023; 29(20): 3133-3144
Published online May 28, 2023. doi: 10.3748/wjg.v29.i20.3133
Safety and effectiveness of vonoprazan-based rescue therapy for Helicobacter pylori infection
Jing Yu, Yi-Ming Lv, Peng Yang, Yi-Zhou Jiang, Xiang-Rong Qin, Xiao-Yong Wang
Jing Yu, Yi-Ming Lv, Peng Yang, Yi-Zhou Jiang, Xiang-Rong Qin, Xiao-Yong Wang, Department of Gastroenterology, The Affiliated Changzhou No. 2 People’s Hospital of Nanjing Medical University, Changzhou 213000, Jiangsu Province, China
Author contributions: Wang XY contributed to conception and design of the study, critical revision, analysis and interpretation of data, drafting the article, revising the article; Yu J and Lv YM contributed to acquisition of data, analysis and interpretation of data, and drafting the article; Yang P, Jiang YZ, and Qin XR contributed to acquisition of data, analysis and interpretation of data; and all authors approved the final version of the manuscript.
Supported by the Changzhou Special Fund for Introducing Foreign Talents, No. CQ20204037; and the Changzhou High-Level Medical Talents Training Project, No. 2022CZBJ051.
Institutional review board statement: The study was reviewed and approved by the Clinical Medical Technical Ethics Committee of the Affiliated Changzhou No. 2 People’s Hospital of Nanjing Medical University [approval. No. (2021) YLJSD004].
Clinical trial registration statement: This study is registered at Chinese Clinical trial Registry. The registration identification number is ChiCTR2200055125.
Informed consent statement: All study participants provided informed written consent prior to the study enrollment and declare that they have no conflict of interest.
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
Data sharing statement: The data that support the findings of this study are available from the corresponding author upon reasonable request.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Xiao-Yong Wang, MD, Assistant Professor, Chief Physician, Postdoc, Department of Gastroenterology, The Affiliated Changzhou No. 2 People’s Hospital of Nanjing Medical University, No. 29 Xinglong Lane, Tianning District, Changzhou 213000, Jiangsu Province, China. wxy20009@126.com
Received: February 27, 2023
Peer-review started: February 27, 2023
First decision: March 13, 2023
Revised: March 25, 2023
Accepted: April 23, 2023
Article in press: April 23, 2023
Published online: May 28, 2023
Processing time: 87 Days and 17.6 Hours
ARTICLE HIGHLIGHTS
Research background

Vonoprazan (VPZ)-containing triple therapies have been shown to contribute to global antimicrobial resistance. Hence, the value of VPZ-based regimens as rescue therapies needs to be explored.

Research motivation

Saccharomyces boulardii (S. boulardii) supplementation significantly improved H. pylori eradication rates and decreased the incidence of adverse events. We are the first to combine S. boulardii supplementation with VPZ-amoxicillin dual therapy (VAS regimen) as a rescue therapy for H. pylori eradication.

Research objectives

To determine the safety and efficacy of the VAS regimen as a rescue treatment for H. pylori infection.

Research methods

We performed a prospective, single-center, clinical trial with the VAS regimen.

Research results

The overall eradication rates calculated using intention-to-treat and per-protocol analyses were 92.6% and 92.3%, respectively. The eradication rate did not differ with the number of treatment failures (P = 0.433). Acceptable eradication rates (> 90%) were achieved in patients with resistance to clarithromycin, metronidazole, and levofloxacin. Most adverse events were mild, and 95.6% patients showed good compliance.

Research conclusions

The VAS regimen is a safe and effective rescue therapy, with an acceptable eradication rate (> 90%), regardless of the number of prior treatment failures.

Research perspectives

Large-scale, multicenter randomized controlled trials in areas with different patterns of antibiotic resistance are needed to confirm our results. It will be necessary to compare the safety and effectiveness of the VPZ-amoxicillin dual therapy regimen with the VAS regimen in the future.