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A Randomized Controlled Non-Inferiority Trial of a 10-Day Vonoprazan–Amoxicillin Dual Therapy for First-Line Helicobacter pylori Eradication in Community Populations

A Randomized Controlled Non-Inferiority Trial of a 10-Day Vonoprazan–Amoxicillin Dual Therapy for First-Line Helicobacter pylori Eradication in Community Populations

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107875
Enrollment
Unknown
Registered
2025-08-20
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-06-15

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

Conditions

Helicobacter pylori infection

Interventions

Experimental Group:Vonoprazan 20mg twice daily and Amoxicillin 1000mg three times daily for 10 days
Control Group:Rabeprazole 10mg twice daily+ Bismuth potassium citrate 240mg twice daily + Amoxicillin 1000mg twice daily + Clarithromycin 500mg twice daily for 14 days

Sponsors

Wuxi Ninth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: This study targets individuals from community populations served by participating healthcare institutions. Eligible participants must meet all of the following criteria: 1. Aged 18 to 70 years; 2. Positive result for the ¹³C or ¹4C urea breath test within the past month. 3. Diagnosed with Helicobacter pylori-positive chronic gastritis by endoscopy within the past three months and meets the indications for H. pylori eradication as outlined in the Sixth National Consensus Report on the Management of Helicobacter pylori Infection; willing to undergo eradication therapy. 4. No prior history of H. pylori eradication therapy. 5. Signed informed consent form.

Exclusion criteria

Exclusion criteria: This study targets individuals from community populations served by participating healthcare institutions. Participants will be excluded if they meet any of the following criteria: 1. Allergy to medications used in this clinical trial; 2. Use of P-CAB,PPI, histamine H2-receptor antagonists, antibiotics, bismuth, or probiotics 1 months before initiating study treatment; 3.Female patients planning pregnancy, as well as pregnant and breastfeeding patients; 4. Use of adrenocorticosteroids, nonsteroidal anti-inflammatory drugs, and anticoagulants; 5. Presence of diseases or clinical conditions, such as cardiac vascular disease,lung disease, liver disease,kidney disease, metabolic disease, mental illness, or malignant tumors, that might interfere with the evaluation of study treatment; 6. Previous esophageal or stomach surgical procedures; 7. Incomplete follow-up or noncompliance with the study treatment;

Design outcomes

Primary

MeasureTime frame
eradication rate;

Secondary

MeasureTime frame
Patient compliance;Incidence of adverse reactions;cost-effectiveness;

Countries

China

Contacts

Public ContactLeyao Zhang

Department of Gastroenterology, Wuxi Ninth People's Hospital Affiliated to Soochow University

zhangleyao@suda.edu.cn+86 138 0618 5265

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 21, 2026