Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Dyspeptic patients with positive for both rapid urease test and stool antigen test

Patients giving written informed consent

Disqualifiers

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

Trial design

Treatments tested in this trial

  • vonoprazan-based triple therapy (VAL regimen)
  • Esomeprazole-based triple therapy (EAL regimen)

Treatment groups

80 Participants
are divided into 2 treatment groups