Article ; Online: Vonoprazan-based triple and dual therapy versus bismuth-based quadruple therapy for Helicobacter pylori infection in China: a three-arm, randomised clinical trial protocol.
2023 Volume 23, Issue 1, Page(s) 231
Abstract: Background: Helicobacter pylori infection and associated diseases are a growing global public health issue. H. pylori infection is the major cause of gastric cancer, over 90% of duodenal ulcers, and over 70% of gastric ulcers. The infection rate of H. ... ...
Abstract | Background: Helicobacter pylori infection and associated diseases are a growing global public health issue. H. pylori infection is the major cause of gastric cancer, over 90% of duodenal ulcers, and over 70% of gastric ulcers. The infection rate of H. pylori is approximately 50%, and approximately 50% of new cases of gastric cancer worldwide occur in China. Bismuth (BI)-based quadruple therapy is recommended as the first-line treatment for H. pylori in China. Vonoprazan (VPZ), a new potassium-competitive acid blocker that can inhibit gastric acid secretion more effectively than proton pump inhibitors (PPIs), has been combined with antibiotics to effectively eradicate H. pylori. In this study, we compared the efficacy and safety of two VPZ-based therapies with that of BI-based therapy for H. pylori treatment. Methods: A three-armed randomised controlled trial (RCT) is being conducted in Shenzhen, with 327 participants recruited from the Gastroenterology Clinic of the University of Hong Kong-Shenzhen Hospital. Patients were diagnosed with H. pylori infection based on a positive Discussion: This study is the a RCT aims to evaluate the efficacy and safety of 14-day VPZ-based triple and dual therapies in comparison with BI-based quadruple therapy. The outcomes of this study may allow treatment recommendations and update drug instructions in China. Trial registration: Chinese Clinical Trial Registry (No. ChiCTR2200056375). Registered on February 4, 2022, https://www.chictr.org.cn/showproj.aspx?proj=141314. |
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MeSH term(s) | Humans ; Bismuth/adverse effects ; Helicobacter pylori ; Stomach Neoplasms/drug therapy ; Drug Therapy, Combination ; Helicobacter Infections/drug therapy ; Helicobacter Infections/diagnosis ; Anti-Bacterial Agents/adverse effects ; Proton Pump Inhibitors/adverse effects ; Amoxicillin/adverse effects ; Treatment Outcome ; Clarithromycin/adverse effects ; Randomized Controlled Trials as Topic |
Chemical Substances | Bismuth (U015TT5I8H) ; 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine ; Anti-Bacterial Agents ; Proton Pump Inhibitors ; Amoxicillin (804826J2HU) ; Clarithromycin (H1250JIK0A) |
Language | English |
Publishing date | 2023-07-07 |
Publishing country | England |
Document type | Clinical Trial Protocol ; Journal Article |
ZDB-ID | 2041351-8 |
ISSN | 1471-230X ; 1471-230X |
ISSN (online) | 1471-230X |
ISSN | 1471-230X |
DOI | 10.1186/s12876-023-02872-7 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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