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Vonoprazan combined with amoxicillin dual therapy for primary eradication of Helicobacter pylori infection: a prospective, multicenter, randomized controlled trial

Vonoprazan combined with amoxicillin dual therapy for primary eradication of Helicobacter pylori infection: a prospective, multicenter, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059309
Enrollment
Unknown
Registered
2022-04-28
Start date
2022-06-15
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Helicobacter pylori infection

Interventions

Control group:Rabeprazole 10mg 3/day + Amoxicillin 1000mg 3/day for 14 days
Experimental group :Vonolasan 20mg 2/day + Amoxicillin 1000mg 3/day for 10 days.

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients, aged between 18-65 years; 2. Patients diagnosed as HP infection by C13/C14 urea breath test or immunohistochemical staining of biopsy samples; 3. Patients with indications of HP eradication and no antagonistic factors; 4. Patients who have not received HP eradication treatment before; 5. Patients who did not take antibiotics, bismuth and antibacterial traditional Chinese medicine 4 weeks before the treatment, and those who did not take PPI, H2 receptor antagonists and other drugs that affect the activity of HP 2 weeks before the treatment; 6. Patients were informed and agreed to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with severe heart, liver, lung, and kidney dysfunction and low immunity (such as HIV infection, under cancer treatment); 2. Patients with penicillin or program-related drug allergy contraindications; 3. Patients with mental illness and communication disorder; 4. Pregnant and lactating patients; 5. Patients with serious gastrointestinal diseases, such as tumors, gastrointestinal bleeding, Zollinger-Ellison syndrome, etc; 6. Patients who are participating in other clinical trials; 7. The researchers think it is not suitable for the patients.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate;

Secondary

MeasureTime frame
Adverse events;Compliance;

Countries

China

Contacts

Public ContactLi Peiyuan

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

pyli@tjh.tjmu.edu.cn+86 13317171760

Outcome results

None listed

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