Helicobacter pylori Infection
Conditions
Interventions
Guided Medication Group:Quantitative PCR of String-Test Collected Gastric Material
Empirical Medication Group:None
Sponsors
The Seventh Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must be between 18 and 75 years of age (inclusive) at the time of signing the informed consent form. 2. Subjects must be candidates for initial eradication treatment for Helicobacter pylori (H. pylori) and must not have received any prior standard anti-H. pylori therapy. 3. Current H. pylori infection must be confirmed by a positive 13C/14C-urea breath test, rapid urease test, or H. pylori culture. 4. In the investigator’s judgment, the subject must be capable of understanding and complying with the requirements of the study protocol. 5. Before any study-related procedures are performed, the subject must provide written informed consent and any required privacy authorization documents, dated accordingly. 6. Female subjects of childbearing potential who have regular sexual activity with a non-sterilized male partner must agree to use two effective methods of contraception from the time of signing the informed consent until the end of the study.
Exclusion criteria
Exclusion criteria: 1. Subjects who present with gastric or duodenal ulcers during endoscopy and show evidence of current or recent bleeding, or who have experienced clinical manifestations of upper or lower gastrointestinal bleeding within 4 weeks prior to randomization; 2. Subjects diagnosed with gastric cancer via endoscopic biopsy or with a history of any malignancy (including MALT lymphoma); 3. Subjects with acquired immunodeficiency syndrome (AIDS) or HIV infection; 4. Subjects who have received any investigational drug (including post-marketing investigational drugs) within 30 days prior to screening, except for those who failed screening and did not actually use the drug; 5. Subjects currently taking medications contraindicated with clarithromycin (e.g., colchicine, pimozide, ergot derivatives, tadalafil, terfenadine, astemizole, cisapride, simvastatin, lovastatin, atorvastatin, etc.; pravastatin and rosuvastatin may be used with caution); 6. Subjects currently taking strong CYP2C19 inhibitors or inducers (e.g., fluconazole, fluoxetine, fluvoxamine, ticlopidine, rifampicin, ritonavir) or strong CYP3A4 inhibitors or inducers (e.g., itraconazole, ketoconazole, indinavir, nelfinavir, ritonavir, saquinavir, telithromycin); 7. Subjects taking medications that may interfere with the 13C-UBT: antibiotics, bismuth preparations, or antiprotozoal drugs within 30 days prior to testing; H2 receptor antagonists, proton pump inhibitors, or other potential interfering substances within 14 days prior to testing; 8. Subjects with a history of allergy or hypersensitivity to proton pump inhibitors, P-cab, amoxicillin, or excipients used in the 13C-urea breath test (mannitol, citric acid, aspartame); 9. Subjects with cutaneous lupus erythematosus or systemic lupus erythematosus; 10. Subjects with Zollinger-Ellison syndrome or other gastric acid hypersecretion disorders, or a history of surgeries that may affect gastric acid secretion (e.g., partial gastrectomy, vagotomy); 11. Subjects with significant central nervous system, cardiovascular, hepatic, pulmonary, renal, metabolic, other gastrointestinal, urinary, reproductive endocrine, or hematological diseases, which, in the investigator’s judgment, may affect the study results or subject safety; 12. Subjects requiring hospitalization or planning surgery during the study, or who have undergone major surgery within 30 days prior to screening; 13. Subjects with a history of alcohol abuse, illicit drug use, or drug addiction, or whose weekly alcohol intake exceeds 21 units (1 unit = 12 oz/300 ml beer, 1.5 oz/25 ml spirits, or 5 oz/100 ml wine); 14. Subjects who are the investigators or immediate family members of the research center, or who have a conflict of interest with the investigators, or who may be pressured into providing consent; 15. Female subjects who are pregnant, breastfeeding, planning to become pregnant within 4 weeks before, during, or after the study, or planning to donate eggs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Genes conferring drug resistance in Helicobacter pylori??; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions and patient tolerability;Medication Compliance;Resistance Profile of Helicobacter pylori to Specific Antibiotics; | — |
Countries
China
Contacts
Public ContactQi Jian
The Seventh Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed