Bismuth-amoxicillin-vonoprazan triple therapy versus bismuth-based quadruple therapy for H. pylori infection

Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy in the First-line Anti-Helicobacter Pylori Treatment

This will test whether a 14-day bismuth-amoxicillin-vonoprazan triple therapy works better and is as safe as a 14-day bismuth-based quadruple therapy for adults with H. pylori infection.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 552 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kaohsiung Medical University (other)
• Locations: 1 site (Kaohsiung City)
• Trial ID: NCT07358130 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, open-label trial enrolling 552 adults with H. pylori infection at hospitals in Taiwan. Participants are randomized 1:1 to receive either 14 days of bismuth-amoxicillin-vonoprazan triple therapy or 14 days of bismuth-rabeprazole-tetracycline-metronidazole quadruple therapy. Follow-up at week 2 checks adherence and side effects, and H. pylori status is evaluated at week 6 using the C13-urea breath test. The study will compare eradication and adverse event rates and analyze how bacterial antibiotic resistance and patient genotypes (CYP3A4, CYP2C19, IL-1B -511) affect outcomes.

Who should consider this trial

Good fit: Adults with confirmed H. pylori infection who are not pregnant or breastfeeding, have no prior gastric surgery, no severe liver cirrhosis or uremia, no recent malignancy, and are not taking contraindicated drugs such as atazanavir or rilpivirine are eligible.

Not a fit: Patients with known hypersensitivity to the study drugs, prior gastric surgery, severe liver cirrhosis or uremia, recent malignancy, pregnancy or breastfeeding, or current use of atazanavir or rilpivirine are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the regimen could raise eradication rates and offer a simpler or better-tolerated first-line option for adults with H. pylori.

How similar studies have performed: Previous studies of vonoprazan-based regimens have shown higher eradication rates than some proton-pump inhibitor regimens, and bismuth quadruple therapy is an established standard, but the specific bismuth-amoxicillin-vonoprazan combination is less extensively tested.

Eligibility criteria

Inclusion Criteria:

* Subjects with Helicobacter pylori infection

Exclusion Criteria:

1. Subjects with known hypersensitivity to the study drug.
2. Subjects with a history of gastric surgery.
3. Subjects with severe liver cirrhosis or uremia.
4. Subjects with a history of malignancy within the past five years.
5. Pregnant or breastfeeding women.
6. Subjects currently receiving treatment with atazanavir sulfate or rilpivirine hydrochloride.

Where this trial is running

Kaohsiung City

• Kaohsiung Medical University Hospital — Kaohsiung City, Taiwan (RECRUITING)

Study contacts

• Principal investigator: Deng-Chyang Wu, MD, PHD — Kaohsiung Medical University
• Study coordinator: Deng-Chyang Wu, MD, PHD

Conditions: Helicobacter Pylori Infection, Helicobacter pylori eradication