Adding bismuth to vonoprazan‑amoxicillin therapy for H. pylori

Effect of Bismuth Add-on to Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Eradication - A Multicenter Randomized Controlled Trial

This study will test whether adding bismuth to a 14-day vonoprazan‑amoxicillin regimen improves H. pylori cure rates in adults who have never had eradication therapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 990 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 1 site (Taipei)
• Trial ID: NCT07576959 on ClinicalTrials.gov

What this trial studies

This open-label randomized controlled trial will enroll about 990 treatment-naïve adults with confirmed H. pylori infection and randomize them to 14 days of vonoprazan‑amoxicillin with bismuth or vonoprazan‑amoxicillin alone. The primary comparison is eradication rate, with safety monitoring and secondary analyses of gut microbiota changes, antibiotic resistance development, and metabolic syndrome markers before and after treatment. The trial is conducted at National Taiwan University Hospital and excludes patients with prior eradication therapy, significant liver or renal disease, pregnancy or breastfeeding, or prior gastrectomy. Results will be analyzed by intention-to-treat and per-protocol approaches to determine superiority or non-inferiority.

Who should consider this trial

Good fit: Adults aged 20 years or older with confirmed H. pylori infection who have not previously received eradication therapy and who can take vonoprazan and amoxicillin.

Not a fit: People who have had prior H. pylori eradication, are pregnant or breastfeeding, have severe liver or kidney disease, prior gastrectomy, or known allergy to the study drugs are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, adding bismuth could increase first-line H. pylori cure rates and reduce the need for later, more complex antibiotic regimens.

How similar studies have performed: Bismuth-containing regimens have improved eradication rates in prior studies, but pairing bismuth specifically with vonoprazan‑amoxicillin as first-line therapy has been less extensively studied.

Eligibility criteria

Inclusion Criteria:

1. Individuals infected with Helicobacter pylori who have not previously undergone eradication therapy.
2. Individuals willing to receive first-line eradication therapy.
3. Study participants must be 20 years of age or older.

Exclusion Criteria:

1. Individuals with a history of gastrectomy (stomach removal surgery).
2. Individuals unsuitable to receive the study drug (e.g., history of allergy or severe adverse effects to the study drug).
3. Pregnant or breastfeeding women.
4. Individuals with severe acute or chronic diseases, such as renal failure, liver cirrhosis, or incurable malignant tumors.
5. Patients with chronic hepatitis (AST \[Aspartate Aminotransferase\] or ALT \[Alanine Aminotransferase\] \> 100 U/L).
6. Individuals unwilling to comply with the treatment plan or sign the informed consent form.

Where this trial is running

Taipei

• National Taiwan University Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Mei-Jyh Chen, MD, PhD

Conditions HELICOBACTER PYLORI INFECTIONS