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Clinical Trial Summary

Helicobacter pylori infection is closely related to gastritis, peptic ulcer, mucosa-associated lymphoid tissue lymphoma and gastric cancer. Eradication of HP can significantly improve and reduce HP-related diseases. International and domestic guidelines recommend a 10-14 day quadruple regimen containing bismuth as first-line treatment, achieving an eradication rate of more than 80%. However, some disadvantages of these quadruple regimens, such as severe adverse reactions, high medical costs and low compliance, prevent their application in clinical practice. Studies at home and abroad have shown that high-dose proton pump inhibitors combined with amoxicillin can be used as the first-line treatment for HP eradication, with good efficacy and compliance and low rate of adverse reactions. And because it is a single antibiotic therapy, we do not expect this regimen to increase antibiotic resistance rates for HP. The maintenance of gastric PH > 6 is one of the key factors for HP eradication. The acid inhibition effect of proton pump mainly depends on the degree of individual metabolism of proton pump. Vonoprazan fumarate, a new competitive potassium acid blocker, is not affected by gene polymorphism, and has the advantage of stronger and longer inhibition effect on gastric acid compared with proton pump inhibitors. In most parts of China, HP is characterized by high infection rate and antibiotic resistance rate, requiring higher eradication rate and safety regimen. This study compared the efficacy and safety of vonoprazan fumarate combined with amoxicillin and bismuth-containing quadruple regimen in first-line HP eradication, in order to find a more suitable regimen for HP eradication.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Helicobacter Pylori Eradication Rate

NCT number NCT05196945
Study type Interventional
Source Sixth Affiliated Hospital, Sun Yat-sen University
Contact
Status Not yet recruiting
Phase Phase 4
Start date March 31, 2022
Completion date February 28, 2023

See also
  Status Clinical Trial Phase
Completed NCT02776371 - Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori Phase 4
Recruiting NCT02833623 - Efficacy of Short-message-based Re-education (SMRE) on Helicobacter Pylori Eradication Phase 4
Completed NCT05719831 - Optimization of Vonoprazan--amoxicillin Dual Therapy for Eradicating Helicobacter Pyloriinfection Phase 3