RecruitingPhase 4NCT07232095

7-Day Vonoprazan, High-Dose Amoxicillin, and Bismuth Therapy

7-Day Vonoprazan-High-Dose Amoxicillin-Bismuth Therapy for First-Line Eradication of Helicobacter Pylori: A Multicenter Randomized Controlled Trial

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

316 participants

Start Date

Jan 8, 2026

Study Type

INTERVENTIONAL

Conditions

Helicobacter Pylori

Summary

The 2024 American College of Gastroenterology (ACG) Clinical Guideline recommends a 14-day vonoprazan-amoxicillin (VA) regimen, consisting of vonoprazan 20 mg twice daily with amoxicillin 1000 mg three times daily, as a first-line treatment for Helicobacter pylori (H. pylori) infection. Our previous study on regimen optimization showed that vonoprazan 20 mg twice daily combined with amoxicillin 1 g three times daily or 750 mg four times daily for 10 days achieved satisfactory eradication rates exceeding 90%, with no significant difference between dosing frequencies. However, when the treatment duration was shortened to 7 days, both dosing schedules failed to reach satisfactory eradication rates, indicating a need for further optimization. Bismuth has antibacterial and synergistic properties, such as disrupting bacterial membranes, suppressing protein synthesis, and reducing virulence factor expression. It may enhance the efficacy of antibiotics. Therefore, this study evaluated the efficacy and safety of a 7-day vonoprazan-high-dose amoxicillin-bismuth (VAB-7) regimen as a first-line treatment for H. pylori infection. Eligible participants in this study will be randomly assigned to one of the following treatment groups based on a pre-generated randomization sequence: Control Group: Vonoprazan combined with high-dose amoxicillin dual therapy for 14 days (VA-14): Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily. Experimental Group: Vonoprazan combined with high-dose amoxicillin and bismuth therapy for 7 days (VAB-7): Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily+Bismuth 220mg twice daily.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

Aged 18 to 70 years, regardless of sex.
Helicobacter pylori infection confirmed by ¹³C or ¹⁴C urea breath test within 1 month before enrollment.
Chronic gastritis with H. pylori infection confirmed by endoscopy within 3 months, meeting the indications for eradication therapy in the Sixth National Consensus Report on the Management of Helicobacter pylori Infection (China), and willing to receive eradication treatment.
No prior H. pylori eradication therapy.
Written informed consent before participation.

Exclusion Criteria7

Known allergy or hypersensitivity to any study medication (vonoprazan, amoxicillin, or bismuth).
Use of potassium-competitive acid blockers (P-CABs), proton pump inhibitors (PPIs), H₂ receptor antagonists, antibiotics, bismuth preparations, or probiotics within 4 weeks before enrollment.
Pregnant or lactating women.
Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or anticoagulants during the study period.
Presence of serious comorbid conditions that may interfere with study evaluation, including significant cardiac, pulmonary, hepatic, renal, metabolic, or psychiatric disorders, or malignancy.
History of gastric or esophageal surgery.
Any condition or factor that may affect compliance or make it difficult for the subject to complete follow-up as required.