Helicobacter pylori
Conditions
Interventions
The group of the two-drug eradication regimen for Helicobacter pylori:Vonoprazan 20mg (twice a day) + antibiotics (amoxicillin 0.1g or tetracycline 0.5g (three times a day) (tetracycline is selected f
The quadruple eradication regimen group for Helicobacter pylori:Bismuth agent + proton pump inhibitor (PPI) + two antibiotics, with a treatment course of 14 days. In this study, the proton pump inhibi
2. Tinidazole 0.5 g (twice a day) / metronidazole 0.4 g (four times a day) + clarithromycin 0.5 g (twice a day) / tetracycline 0.5 g (four times a day) / minocycline 0.1 g (four times a day)
Sponsors
Fujian Medical University
Eligibility
Sex/Gender
All
Age
35 Years to 64 Years
Inclusion criteria
Inclusion criteria: (1) No history of antibiotic allergy; (2) Age between 35 and 64 years old; (3) Positive for Helicobacter pylori infection in Carbon-14 breath test; (4) Agree to participate in this project and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Subjects who have used acid-suppressing drugs such as proton pump inhibitors, potassium-competitive acid blockers, or histamine H2 receptor antagonists within 2 weeks before enrollment, or who have used antibiotics, bismuth preparations, or traditional Chinese medicines with antibacterial effects within 4 weeks before enrollment; (2) Women who are currently pregnant or breastfeeding; (3) Subjects who have undergone or plan to undergo surgeries that affect gastric acid secretion, such as upper gastrointestinal resection or vagotomy; (4) Subjects with a history of Zollinger-Ellison syndrome or other conditions of excessive gastric acid secretion; (5) Subjects with severe systemic diseases, major organ diseases such as heart, lung, or brain diseases, liver or kidney insufficiency, malignant tumors, or other diseases; (6) Subjects known to be allergic to Kapravir, bismuth, or related excipients (such as mannitol, microcrystalline cellulose, croscarmellose sodium, hypromellose, magnesium stearate, etc.); (7) Pregnant or breastfeeding women; (8) Long-term alcohol abuse or any other conditions that increase the risk of adverse reactions to treatment; (9) Subjects deemed by the investigator as unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether the treatment for Helicobacter pylori infection is successful in eradication;The incidence and death of gastric cancer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evolution and drug resistance changes of Helicobacter pylori strains in gastric tissue samples from treatment failure patients;Changes in the metabolome and immune indicators of the organism; | — |
Countries
China
Contacts
Public ContactWeimin Ye
Fujian Medical University
Outcome results
None listed