A Pilot Study Comparing 14-Day Vonoprazan-Based Dual, Triple, Bismuth Quadruple, Reverse Hybrid, and Lansoprazole-Based Therapies for First-Line Treatment of Helicobacter Pylori Infection

What this Trial Is About

This research aims to compare the effectiveness and safety of various vonoprazan-based and lansoprazole-based therapies for first-line treatment of Helicobacter pylori infection in adults aged 20 years and older. The trial investigates different drug combinations including dual, triple, quadruple, and reverse hybrid therapies, addressing the question of which regimen is superior or non-inferior, especially in areas with high clarithromycin resistance. It also explores long-term effects on gut microbiota, antibiotic resistance, TMAO levels, and metabolic parameters. Participants will be randomly assigned to one of eight treatment groups receiving either vonoprazan- or lansoprazole-based therapies with varying combinations and durations, ranging from 7 to 14 days. Those who do not achieve eradication after first-line therapy may receive further randomized treatment with vonoprazan-based levofloxacin triple or reverse hybrid therapies. The study includes detailed genetic and microbiological testing to understand resistance mechanisms and drug effects. Throughout the study, participants will undergo multiple assessments including stool and oral sample collections for microbiome sequencing at baseline, week 2, week 8, year 1, and year 2. Metabolic tests and a modified carnitine challenge test to assess TMAO production will also be conducted at these time points. The primary outcome focuses on eradication rate within 8 to 12 weeks, while secondary outcomes include treatment compliance, adverse events, and overall eradication after two treatments, with long-term follow-up for microbiome and metabolic changes.

Comparison of Vonoprazan-based Versus Lansoprazole-based Triple Therapy, High Dose Dual Therapy, Bismuth and Non-bismuth Quadruple Therapy in the First-line Treatment of Helicobacter Pylori Infection