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A prospective clinical study of different vonoprazan-based regimens for primary eradication of Helicobacter pylori

A prospective clinical study of different vonoprazan-based regimens for primary eradication of Helicobacter pylori

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072857
Enrollment
Unknown
Registered
2023-06-27
Start date
2023-07-10
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Helicobacter pylori infection

Interventions

Dual therapy group:Vonoprazan 20 mg Bid, orally half an hour before breakfast and dinner
Amoxicillin 1 g Tid, orally half an hour after breakfast, lunch and dinner. 10 days.
Triple Therapy Group:Vonoprazan 20 mg Bid, orally half an hour before breakfast and dinner
Amoxicillin 1 g Bid, orally half an hour after breakfast and dinner
Clarithromycin 500 mg Bid, orally half an hour after breakfast and dinner. 14 days.
Quadruple therapy group:Vonoprazan 20 mg Bid, orally half an hour before breakfast and dinner
Bismuth Citrate Potassium 240 mg Bid, orally half an hour before breakfast and dinner
Amoxicillin 1 g Bid, orally half an hour before breakfast and dinner
Clarithromycin 500 mg Bid, orally half an hour after breakfast and dinner. 10 days.

Sponsors

The First Affiliated Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-69 years; 2. H. pylori infection was diagnosed by postive results in any one of the following tests: 13C or 14C-urea breath test, immunohistochemical staining, H. pylori culture, or fecal H. pylori antigen test; 3. No previous history of H. pylori eradication therapy; 4. Willingness to participate in the study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to any of the drugs used in this study; 2. Patients who had history of gastric surgery; 3. Patients with insufficiency in vital organs, such as the lungs, heart, liver and kidneys; 4. Patients who had history of taking antibiotics, bismuth, traditional Chinese medicine with antibacterial effect within four weeks, or proton-pump inhibitor, H2 receptor antagonists, non-steroidal anti-inflammatory drug within two weeks before inclusion; 5. Pregnant or lactating women; 6. Patients with psychiatric symptoms, drug addiction, severe neurocognitive disorders and other poor compliance or unable to cooperate.

Design outcomes

Primary

MeasureTime frame
H. pylori eradication rate;

Secondary

MeasureTime frame
Compliance;Adverse events;

Countries

China

Contacts

Public ContactZhang Jinyan

The First Affiliated Hospital of Xiamen University

zjywyq2002@163.com+86 151 6004 2319

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 9, 2026