Helicobacter pylori infection
Conditions
Interventions
keverprazan-amoxicillin dual treatment:Keverprazan tablets (20mg): Take 2 tablets each time, twice daily, orally 30 minutes before meals, 14days.
Amoxicillin capsules (1.0g): Take 1.0g three times dai
vonoprazan-amoxicillin dual treatment:Vonoprazan tablets (20mg): Take 2 tablets each time, twice daily, orally 30 minutes before meals, 14days.
Amoxicillin capsules (1.0g): Take 1.0g three times daily
Sponsors
The Eighth Affiliated Hospital, Sun Yat-sen University (Futian, Shenzhen)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-75 years old, males or females; 2. voluntarily sign the written informed consent approved by the ethics committee and agree to participate in this study before the research procedure; 3. able to understand and comply with the protocol, and agree to participate in all research visits, sign the informed consent; 4. Helicobacter pylori infection (13C urea breath test or histological examination); 5. without eradication history; 6. agree to contraception with appropriate medical methods during the research process.
Exclusion criteria
Exclusion criteria: 1. having participated in any other clinical researchs within 3 months prior to the first administration of the study drug; 2. received omeprazole, rabeprazole, lansoprazole, tegoprazan, vonoprazan within 2 weeks, or antibiotic within 4 weeks before enrollment; 3. acute upper gastrointestinal bleeding, gastric or duodenal ulcers, acute gastric or duodenal mucosal injury, atrophic gastritis within 30 days before the screening period; 4. history of Zollinger-Ellison syndrome or excessive gastric acid secretion; 5. having received or planning to receive surgery affecting gastric acid secretion (such as upper gastrointestinal resection, vagus nerve incision, etc); 6. having warning symptoms suggesting possible gastrointestinal malignancy, such as odynophagia, severe dysphagia, bleeding, weight loss, anemia or hematochezia, except those who have been excluded from malignancy through endoscopy; 7. cannot undergo upper gastrointestinal endoscopy; 8. allergy to vonoprazan or keverprazan (including preparations, excipients); 9. having taken drugs that may affect gut microbiota within 3 months: metformin, acarbose, aspirin, laxatives, probiotics, antibiotics, etc., and taken yogurt within 1 week; 10. pregnancy or breast feeding; 11. serious liver, kidney, cardiovascular, respiratory, gastrointestinal, endocrine, hematological, central nervous system or mental disorders that may affect the safety of the subjects or the interpretation of results; 12. any of the following abnormal laboratory results at the screening stage: AST > upper limit of normal value, ALT > upper limit of normal value, total bilirubin > upper limit of normal value, creatinine > 1.5 times the upper limit of normal value; 13. abnormal electrocardiogram (ECG), including severe arrhythmia, multifocal premature ventricular contractions (PVC), second-degree or higher atrioventricular conduction block.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HP eradication rate;blood routine, liver function;vital signs; | — |
Secondary
| Measure | Time frame |
|---|---|
| change in diversity of gut microbiota;change in diversity of beta-lactam-related resistance genes; | — |
Countries
China
Contacts
Public ContactTing Zhou
The Eighth Affiliated Hospital, Sun Yat-sen University (Futian, Shenzhen)
Outcome results
None listed