The goal of this clinical trial is to compare the efficacy and safety of vonoprazan-based levofloxacin-containing triple therapy with esomeprazole-based levofloxacin-containing triple therapy for eradication of Helicobacter pylori infection in adults with dyspepsia.
The main questions it aims to answer are whether vonoprazan-based triple therapy achieves a higher eradication rate of H. pylori, whether it provides greater improvement in dyspeptic symptoms, and what adverse effects are associated with each regimen.
Researchers will compare the two treatment regimens to determine which is more effective for H. pylori eradication.
Participants with confirmed H. pylori infection will be randomly assigned to receive either vonoprazan-based or esomeprazole-based triple therapy for 14 days.
Four weeks after completion of therapy, participants will undergo repeat stool antigen testing to assess eradication.
Drug compliance, adverse effects, and dyspeptic symptom scores will be recorded during follow-up.
Participants with endoscopic mucosal lesions at baseline will undergo follow-up endoscopy for reassessment.
Age ≥ 18 years
Dyspeptic patients with positive for both rapid urease test and stool antigen test
Patients giving written informed consent
Treatment with a proton pump inhibitor, H2-receptor antagonist within the last 2 weeks, prior to the study
Treatment with antibiotics or bismuth preparation within 4 weeks prior to the study
Previous H. pylori eradication therapy
Gastric or duodenal ulcer with current or recent bleeding on endoscopy
Parallel
vonoprazan-based triple therapy (VAL regimen)
Drugvonoprazan 20 mg twice daily (30 minutes before meal), Amoxicillin 1 g twice daily (After meal), Levofloxacin 500 mg once daily for 14 days
Esomeprazole-based triple therapy (EAL regimen)
DrugEsomeprazole 20 mg twice daily (30 minutes before meal), Amoxicillin 1 g twice daily (After meal), Levofloxacin 500 mg once daily for 14 days
H. pylori Eradication Rate
Proportion of participants with confirmed eradication of Helicobacter pylori, defined as a negative stool antigen test performed 4 weeks after completion of therapy.
Endoscopic Mucosal Healing rate
Proportion of participants with healed gastric or duodenal mucosal lesions assessed by repeat upper gastrointestinal endoscopy 4 weeks after completion of therapy.
Change in dyspeptic symptom severity score
Dyspeptic symptoms were assessed using an 8-item, 5-point Likert scale at baseline and 4 weeks after completion of therapy. Each item was scored from 1 (no symptom) to 5 (very severe), yielding a total score ranging from 8 to 40. Lower scores indicated fewer symptoms. Improvement was defined as a reduction in total symptom score from baseline
Adverse Events
Incidence and type of treatment-related adverse events reported during and up to 4 weeks after completion of therapy.
Compliance to Therapy
Proportion of participants who complete the prescribed 14-day therapy as per protocol.
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