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

NCT07232095 | Recruiting Phase 4

• 1 other identifier: 2025JSHERO4
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori

Keywords

Helicobacter Pylori; Vonoprazan; Amoxicillin; Bismuth; Eradication

Outcome Measures

Primary Outcomes (1)

• H. pylori eradication rate

  Rate of H. pylori successfully eradicated; The confirmation of H. pylori status was evaluated by Urea breath test.

  4-6 weeks after treatment completion

Secondary Outcomes (3)

• Patient compliance

  1 day after treatment completion

• Adverse events

  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

  1 day after the procedure

Study Arms (2)

7-day Vonoprazan-High-dose Amoxicillin-Bismuth therapy

EXPERIMENTAL

Vonoprazan 20mg twice daily+Amoxicillin 1g three times daily+Bismuth 220mg twice daily for 7 days

Drug: VAB-7

14-day Vonoprazan-Amoxicillin dual therapy

ACTIVE COMPARATOR

Vonoprazan 20mg twice daily and Amoxicillin 1g three times daily for 14 days

Drug: VA-14

Interventions

VAB-7 DRUG

Vonoprazan 20mg twice daily+Amoxicillin 1g three times daily+Bismuth 220mg twice daily for 7 days

7-day Vonoprazan-High-dose Amoxicillin-Bismuth therapy

VA-14 DRUG

Vonoprazan 20mg twice daily and Amoxicillin 1g three times daily for 14 days

14-day Vonoprazan-Amoxicillin dual therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Central Study Contacts

Feng Ye, PhD

CONTACT

86+13815897873; fengye@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: January 8, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)