Comparing Dexlansoprazole, Lansoprazole, and Vonoprazan with Levofloxacin-Based Triple Therapy for Treating Helicobacter pylori Infection A Three-Arm Randomized Study in Adults

What this Trial Is About

This research aims to compare the effectiveness of three different proton pump inhibitors PPIs combined with Levofloxacin and Amoxicillin for treating Helicobacter pylori infections. H. pylori is a widespread infection that can cause stomach inflammation, ulcers, and increase the risk of stomach cancer, especially in regions with high antibiotic resistance like Pakistan. The study is a Phase 4, randomized controlled trial involving adult patients diagnosed with H. pylori who are not currently receiving treatment. Participants will be randomly assigned to one of three treatment groups Dexlansoprazole 60mg twice daily, Lansoprazole 30mg twice daily, or Vonoprazan 20mg twice daily, each combined with Levofloxacin 500mg once daily and Amoxicillin 1g twice daily for 14 days. The study will take place over 12 months at multiple healthcare centers across Pakistan. The main goal is to measure how well each treatment eradicates H. pylori infection, with follow-up assessments six weeks after treatment. During the study, participants will complete questionnaires about their gastrointestinal symptoms using the Gastrointestinal Symptom Rating Scale GSRS at the start and after treatment. The success of eradication will be measured by a Urea Breath Test UBT at follow-up. Researchers will also monitor any side effects and treatment adherence. Statistical analysis will compare eradication rates and symptom improvements among the three treatment groups, helping to identify the most effective therapy for this infection in high-resistance settings.

CURE-H. Pylori: A Trial on the Combination of Anti-Ulcerants and Levofloxacin-Based Therapy for Helicobacter Pylori Eradication