Actively Recruiting
Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication
Led by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Updated on 2026-04-22
80
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Vonoprazan-based Versus Esomeprazole-based Triple Therapy for Helicobacter Pylori Eradication
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Dyspeptic patients testing positive for both rapid urease test and stool antigen test for H. pylori
- Patients who provide written informed consent
You will not qualify if you...
- Use of proton pump inhibitors or H2-receptor antagonists within 2 weeks before the study
- Use of antibiotics or bismuth preparations within 4 weeks before the study
- Previous treatment for H. pylori eradication
- Current or recent bleeding gastric or duodenal ulcers seen on endoscopy
- Significant upper or lower gastrointestinal bleeding within 4 weeks
- Regular use of NSAIDs or steroids
- History of surgery affecting gastric acid secretion, such as upper gastrointestinal resection or vagotomy
- Known malignancy including MALToma
- Advanced co-morbid conditions like chronic liver disease, chronic kidney disease, cardio-respiratory failure, or thyroid disease
- Chronic alcohol abuse, illegal drug use, or drug addiction within the past 12 months
- Pregnant, lactating women or those planning pregnancy during the study
- Known allergy to vonoprazan, proton pump inhibitors, amoxicillin, or levofloxacin
- Current use of colchicine
- Abnormal lab results at screening such as serum creatinine greater than 2 mg/dl or SGPT over twice the upper limit of normal
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh
Not Yet Recruiting
2
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh
Actively Recruiting
Research Team
S
Syeda Mubashsharah Mahfuz, MBBS
CONTACT
M
Md. Ahid Iqbal Khokan, MBBS, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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