Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication (NCT07537634) | Clinical Trial Compass
RecruitingPhase 4
Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication
Bangladesh80 participantsStarted 2026-04-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years
. Dyspeptic patients with positive for both rapid urease test and stool antigen test
. Patients giving written informed consent
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
H. pylori Eradication Rate
Timeframe: 4 weeks after completion of 14-day therapy
Trial details
NCT IDNCT07537634
SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh