Comparing vonoprazan versus esomeprazole triple therapy to clear H. pylori

Comparison Between Vonoprazan-Based Triple Therapy and Esomeprazole-Based Triple Therapy for Eradication of Helicobacter Pylori Infection: An Open-Label Randomized Controlled Trial

This trial tests whether a 14-day vonoprazan-based levofloxacin triple therapy clears H. pylori and eases dyspepsia better than a 14-day esomeprazole-based regimen in adults with confirmed infection.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Academic / other)
• Locations: 2 sites (Dhaka and 1 other locations)
• Trial ID: NCT07537634 on ClinicalTrials.gov

What this trial studies

This open-label, randomized controlled trial at Bangabandhu Sheikh Mujib Medical University compares two 14-day levofloxacin-containing triple regimens—one using vonoprazan and one using esomeprazole—for adults with dyspepsia and confirmed H. pylori infection. Eligible participants must have positive stool antigen and rapid urease tests and will undergo endoscopy with biopsies before randomization in a 1:1 ratio. Treatment adherence, adverse effects, and dyspeptic symptom scores will be recorded during therapy. Eradication will be determined by stool antigen testing four weeks after completing therapy to compare cure rates between the two groups.

Who should consider this trial

Good fit: Adults aged 18 or older with dyspepsia and confirmed H. pylori infection by both stool antigen and rapid urease tests who can undergo endoscopy and meet the trial's exclusion criteria are ideal candidates.

Not a fit: Patients with known antibiotic-resistant H. pylori, recent PPI or antibiotic use, prior eradication therapy, significant comorbidities, pregnancy or lactation, or other listed exclusions are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the vonoprazan-based regimen could produce higher H. pylori eradication rates and quicker symptom relief with an acceptable safety profile.

How similar studies have performed: Previous trials have reported that vonoprazan-based regimens can yield higher eradication rates than proton pump inhibitor regimens in some populations, though results vary and levofloxacin resistance can limit success.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Treatment with a proton pump inhibitor, H2-receptor antagonist within the last 2 weeks, prior to the study
2. Treatment with antibiotics or bismuth preparation within 4 weeks prior to the study
3. Previous H. pylori eradication therapy
4. Gastric or duodenal ulcer with current or recent bleeding on endoscopy
5. Significant upper or lower gastrointestinal bleeding within 4 weeks
6. Patients with regular intake of NSAIDs or steroids
7. Surgery that might affect gastric acid secretion e.g., upper GI resection or vagotomy
8. Known case of malignancy, including MALToma
9. Advanced co-morbidities (e.g., CLD, CKD, cardio-respiratory failure, known thyroid disease)
10. Chronic alcohol abuse, chronic illegal drug use, or drug addiction within the past 12 months
11. Pregnant, lactating woman or intend to become pregnant within the study period
12. History of hypersensitivity to vonoprazan, PPIs, amoxicillin, and/or levofloxacin
13. On colchicine
14. 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 this trial is running

Dhaka and 1 other locations

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

Study contacts

• Principal investigator: Syeda Mubashsharah Mahfuz, MBBS — Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Study coordinator: Syeda Mubashsharah Mahfuz, MBBS

Conditions Helicobacter Pylori Infection; Dyspepsia; Peptic Ulcer Disease; Helicobacter Pylori; H Pylori; Helicobacter pylori; Helicobacter pylori eradication; Vonoprazan