Helicobacter pylori Infection
Conditions
Interventions
Control Group (Vonoprazan-Amoxicillin Dual Therapy):Regimen: Oral vonoprazan fumarate tablets 20 mg bid, before breakfast and dinner, combined with oral amoxicillin capsules 1 g tid, after breakfast,
Sponsors
Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Study participants must meet all of the following criteria to be eligible for inclusion in this study: 1. Be aged between 18 and 70 years; 2. Have a confirmed active Hp infection, as evidenced by a positive result in any one of the following tests: 13C or 14C urea breath test, rapid urease test, faecal antigen test or histological examination; 3. Be a mentally alert and competent study participant, capable of legally and independently understanding and signing the informed consent form.
Exclusion criteria
Exclusion criteria: Study participants will be excluded from this study if they meet any of the following criteria: 1. Participants with a known or documented history of allergy to any component of the study medication regimen; 2. Participants who have used a proton pump inhibitor (PPI) or a potassium-competitive acid blocker (PCAB) within 2 weeks prior to screening; 3. Participants who have used bismuth compounds or any antibiotics (including traditional Chinese medicinal ingredients with antibacterial properties) within 4 weeks prior to screening; 4. Acute upper gastrointestinal bleeding within the past week; 5. History of gastrectomy; 6. Concurrent malignant tumours, severe renal impairment (glomerular filtration rate <30 ml/min/1.73 m²), severe hepatic impairment (Child-Pugh Class C) or other serious systemic diseases; 7. Pregnant or breastfeeding women; 8. Study participants currently taking medications known to interact with the study drug, and for whom safe discontinuation during the study period is not feasible. These include, but are not limited to: warfarin, phenytoin sodium, carbamazepine, allopurinol, tacrolimus, etc.;
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