A Phase 4 interventional study of VAB-7 and VA-14 in Helicobacter Pylori, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 4, Interventional, and Treatment
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.
Helicobacter pylori (H. pylori) is a Gram-negative bacterium that chronically colonizes the gastric mucosa, leading to persistent inflammation and mucosal injury. Eradication of H. pylori can prevent the recurrence of peptic ulcers, treat gastric mucosa-associated lymphoid tissue (MALT) lymphoma, and reduce the risk of gastric cancer. However, with the increasing prevalence of antibiotic resistance, eradication rates have gradually declined worldwide, creating an urgent need for more effective, safe, and practical treatment regimens.
In recent years, vonoprazan, a novel and potent potassium-competitive acid blocker (P-CAB), has emerged as an alternative to conventional proton pump inhibitors (PPIs). Its rapid onset and strong acid suppression provide an ideal environment for amoxicillin to maintain stable bactericidal activity. The vonoprazan-amoxicillin (VA) dual therapy has demonstrated excellent eradication efficacy and safety in several clinical studies and has been recommended by the 2024 American College of Gastroenterology (ACG) Clinical Guideline as a first-line treatment for H. pylori infection.
Our previous multicenter trial 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 above 90%, with no significant difference between dosing frequencies. However, shortening the treatment duration to 7 days resulted in slightly lower eradication rates (below 90%), indicating that the shortened regimen may require further optimization to maintain high efficacy.
Bismuth compounds exhibit multiple antimicrobial and synergistic effects. They can inhibit H. pylori adhesion to the gastric mucosa, disrupt bacterial membrane integrity, suppress protein synthesis, and reduce the expression of virulence factors. In addition, bismuth enhances the activity of antibiotics such as amoxicillin by reducing bacterial resistance and increasing local drug concentration in the gastric mucosa. Previous studies have shown that 7-day bismuth-containing regimens(with amoxicillin and tetracycline) can achieve comparable eradication rates to 14-day regimens.
This study was designed to evaluate whether the addition of bismuth could improve the efficacy of a short-course vonoprazan-amoxicillin regimen. Specifically, the trial investigates the 7-day vonoprazan-high-dose amoxicillin-bismuth (VAB-7) regimen as a first-line treatment for H. pylori infection.
This multicenter, randomized, controlled trial aims to compare the efficacy and safety of VAB-7 with the standard 14-day vonoprazan-high-dose amoxicillin dual therapy (VA-14). The primary endpoint is the eradication rate of H. pylori confirmed by a ¹³C-urea breath test performed at least 4 weeks after treatment completion. Secondary outcomes include adverse event rates, patient adherence, and cost-effectiveness.
The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vonoprazan 20mg twice daily+Amoxicillin 1g three times daily+Bismuth 220mg twice daily for 7 days
Drug: VAB-7
Vonoprazan 20mg twice daily and Amoxicillin 1g three times daily for 14 days
Drug: VA-14
Vonoprazan 20mg twice daily+Amoxicillin 1g three times daily+Bismuth 220mg twice daily for 7 days
Vonoprazan 20mg twice daily and Amoxicillin 1g three times daily for 14 days
H. pylori eradication rate
Rate of H. pylori successfully eradicated; The confirmation of H. pylori status was evaluated by Urea breath test.
Time frame: 4-6 weeks after treatment completion
Patient compliance
Good compliance was defined as achieving ≥80% of drugs in the regimes and bad compliance was defined as achieving \<80% of drugs.
Time frame: 1 day after treatment completion
Adverse events
Adverse drug reactions, including the incidence of both overall and serious adverse events, will be assessed using a standardized questionnaire.
Time frame: For the 7-day intervention: assessment on Day 3 and Day 7; For the 14-day intervention: assessment on Day 7 and Day 14.
Cost-effectiveness ratio
The cost-effectiveness ratio is defined as the total cost per patient for one course of H. pylori eradication treatment divided by the H. pylori eradication rate.
Time frame: 1 day after the procedure
Plan to share: No
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The First Affiliated Hospital with Nanjing Medical University