NCT07358130 Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy
| NCT ID | NCT07358130 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kaohsiung Medical University |
| Condition | Helicobacter Pylori Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 552 participants |
| Start Date | 2025-10-21 |
| Primary Completion | 2027-11-15 |
Trial Parameters
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Brief Summary
(1) To compare the efficacy and safety of a 14-day bismuth-amoxicillin-vonoprazan triple therapy versus a 14-day bismuth-based quadruple therapy as first-line treatments for H. pylori infection, and (2) To investigate the influence of H. pylori antibiotic resistance, along with host CYP3A4, CYP2C19, and IL-1B -511 genotypes, on the eradication efficacy of H. pylori therapies.
Eligibility Criteria
Inclusion Criteria: * Subjects with Helicobacter pylori infection Exclusion Criteria: 1. Subjects with known hypersensitivity to the study drug. 2. Subjects with a history of gastric surgery. 3. Subjects with severe liver cirrhosis or uremia. 4. Subjects with a history of malignancy within the past five years. 5. Pregnant or breastfeeding women. 6. Subjects currently receiving treatment with atazanavir sulfate or rilpivirine hydrochloride.