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

RecruitingPhase 4Ages 18 Years - 70 YearsAllThe First Affiliated Hospital with Nanjing Medica…
NCT07232095 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 f

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Aged 18 to 70 years, regardless of sex. 2. Helicobacter pylori infection confirmed by ¹³C or ¹⁴C urea breath test within 1 month before enrollment. 3. 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. 4. No prior H. pylori eradication therapy. 5. Written informed consent before participation. Exclusion Criteria: 1. Known allergy or hypersensitivity to any study medication (vonoprazan, amoxicillin, or bismuth). 2. 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. 3. Pregnant or lactating women. 4. Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or anticoagulants during the study period. 5. Presence of serious comorbid conditions that may interfere with study evaluation, including significant cardiac, pulmonary, hepatic, renal, metabolic, or psychiatric disorders, or malignancy. 6. History of gastric or esophageal surgery. 7. Any condition or factor that may affect compliance or make it difficult for the subject to complete follow-up as required.
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What it tests

  • VAB-7
  • VA-14
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Where

1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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