Actively Recruiting
7-Day Vonoprazan, High-Dose Amoxicillin, and Bismuth Therapy
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-04-08
316
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
7-Day Vonoprazan, High-Dose Amoxicillin, and Bismuth Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years, regardless of sex
- Helicobacter pylori infection confirmed by urea breath test within 1 month before enrollment
- Chronic gastritis with H. pylori infection confirmed by endoscopy within 3 months, meeting indications for eradication therapy
- No prior H. pylori eradication therapy
- Provided written informed consent before participation
You will not qualify if you...
- Allergy or hypersensitivity to vonoprazan, amoxicillin, or bismuth
- Use of acid blockers, antibiotics, bismuth, or probiotics within 4 weeks before enrollment
- Pregnant or lactating women
- Use of NSAIDs, corticosteroids, or anticoagulants during the study
- Serious heart, lung, liver, kidney, metabolic, psychiatric disorders, or cancer
- History of gastric or esophageal surgery
- Any condition affecting compliance or ability to complete follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
F
Feng Ye, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here