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A multicenter randomized controlled study on 7-day vonoprazan - high-dose amoxicillin-bismuth therapy for the primary treatment of patients with Helicobacter pylori infection

A multicenter randomized controlled study on 7-day vonoprazan - high-dose amoxicillin-bismuth therapy for the primary treatment of patients with Helicobacter pylori infection

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113657
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection

Interventions

VAB-7 group:Vonoprazan 20mg twice daily+Amoxicillin 1g three times daily+Bismuth 220mg twice daily for 7 days
VA-14 group:Vonoprazan 20mg twice daily and Amoxicillin 1g three times daily for 14 days

Sponsors

The First Affiliated Hospital with Nanjing Medical University(Jiangsu Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Eradication rate;

Secondary

MeasureTime frame
Incidence of adverse events;Compliance;Cost-effectiveness;

Countries

China

Contacts

Public ContactFeng Ye

Department of Gastroenterology, Jiangsu Provincial People's Hospital

fengye@njmu.edu.cn+86 138 1589 7873

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026