Helicobacter pylori Infection
Conditions
Interventions
Sponsors
Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: To be eligible for inclusion in this study, participants must meet all of the following criteria: 1. Age >= 18 years, with confirmed Helicobacter pylori (H. pylori) infection and no history of prior eradication therapy. 2. Confirmed active H. pylori infection, defined as a positive result on any of the following tests: 13C or 14C urea breath test (UBT), rapid urease test (RUT), stool antigen test, or histological examination. 3. Conscious and mentally competent participants who are legally capable of independently understanding and signing the written informed consent form (ICF).
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study: 1. History of prior H. pylori eradication therapy. 2. Known or documented hypersensitivity/allergy to any component of the study drug regimen. 3. Use of proton pump inhibitors (PPIs) or potassium-competitive acid blockers (P-CABs) within 2 weeks prior to screening. 4. Use of bismuth agents or any antibiotics (including traditional Chinese medicines with antibacterial properties) within 4 weeks prior to screening. 5. Acute upper gastrointestinal bleeding within 1 week prior to enrollment. 6. History of gastrectomy. 7. Concomitant malignant tumors, severe renal impairment (estimated glomerular filtration rate, eGFR< 30 mL/min/1.73m², severe hepatic impairment (Child-Pugh Class C), or other severe systemic diseases. 8. Pregnant or lactating women. 9. Current use of medications with established significant interactions with the study drugs that cannot be safely discontinued during the study period, including but not limited to: warfarin, phenytoin sodium, carbamazepine, allopurinol, and tacrolimus. 10. Any other conditions that, in the opinion of the investigator, render the participant unsuitable for the study, such as major medical illnesses or psychiatric disorders that would preclude compliance with the protocol or interfere with follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Helicobacter pylori eradication rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Medication adherence of study participants; | — |
Countries
China
Contacts
Public ContactXiaowei Liu, Yu Peng
Xiangya Hospital, Central South University
Outcome results
None listed