Comparing 14-Day Bismuth-Vonoprazan-Amoxicillin Triple Therapy to Vonoprazan-Amoxicillin Dual Therapy for First-Time Helicobacter Pylori Treatment

What this Trial Is About

Researchers are evaluating the effectiveness and safety of two treatment approaches for first-time Helicobacter pylori infection. The study compares a 14-day triple therapy that includes bismuth, vonoprazan, and amoxicillin with a 14-day dual therapy of vonoprazan and amoxicillin without bismuth. The trial also examines how these treatments affect gut bacteria, antibiotic resistance development, and changes in metabolic syndrome markers before and after treatment. Participants will be randomly assigned to one of two groups one receiving the bismuth-supplemented triple therapy and the other receiving the dual therapy without bismuth. Both treatments last for 14 days. This is an open-label, randomized controlled trial designed to assess whether adding bismuth enhances treatment effectiveness or is at least not worse than the dual therapy alone. During the study, participants will be monitored for eradication of H. pylori infection using intention-to-treat analysis at 6 to 8 weeks after treatment. Secondary assessments include per-protocol eradication rates and monitoring for any adverse events. The study involves treatment adherence, safety monitoring, and evaluation of gut microbiota changes over the course of the trial. Participants will be involved from the start of treatment through follow-up assessments.

Effect of Bismuth Add-on to Dual Therapy for Helicobacter Pylori Eradication