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

Recruiting now · Phase 4

Conditions studied: Helicobacter Pylori Infection, Dyspepsia, Peptic Ulcer Disease, Helicobacter Pylori, H Pylori

In brief

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.

Key facts

Study ID

NCT07537634

Run by

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

People needed

80

Starts

2026-04-15

Expected to finish

2026-08-14

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Dyspeptic patients with positive for both rapid urease test and stool antigen test
• Patients giving written informed consent

You may not qualify if…

• 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
• Significant upper or lower gastrointestinal bleeding within 4 weeks
• Patients with regular intake of NSAIDs or steroids
• Surgery that might affect gastric acid secretion e.g., upper GI resection or vagotomy
• Known case of malignancy, including MALToma
• Advanced co-morbidities (e.g., CLD, CKD, cardio-respiratory failure, known thyroid disease)
• Chronic alcohol abuse, chronic illegal drug use, or drug addiction within the past 12 months
• Pregnant, lactating woman or intend to become pregnant within the study period
• History of hypersensitivity to vonoprazan, PPIs, amoxicillin, and/or levofloxacin
• On colchicine
• Subjects with abnormal laboratory test at the start of the screening period:
• S. creatinine > 2 mg/dl SGPT > 2 x Upper limit of normal

Where it is running

• Bangabandhu Sheikh Mujib Medical University — Dhaka, Bangladesh (enrolling)
• Bangabandhu Sheikh Mujib Medical University — Dhaka, Bangladesh

Full record on ClinicalTrials.gov

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