Helicobacter Pylori Eradication and Follow-up
Phase 4
Recruiting
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT05061732
- Lead Sponsor
- Shanghai Zhongshan Hospital
- Brief Summary
This randomized controlled clinical trial will estimate the eradication efficacy of different therapy for Helicobacter pylori treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4447
Inclusion Criteria
- Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
- 18-75 years old on the day of signing the ICF.
- Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
Exclusion Criteria
- Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
- Subjects or guardians refused to participate in the trial.
- Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
- Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.
- Pregnant or lactating women.
- Active peptic ulcer.
- allergic to drugs used in the trial.
- any other circumstances that are not suitable for recruitment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RBAM4 Bismuth potassium citrate Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g tid for 14 days RBDM Bismuth potassium citrate Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days RBCL Bismuth potassium citrate Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levofloxacin 0.5 g qd for 14 days RBAM Metronidazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days RA Rabeprazole Rabeprazole 20 mg bid, and Amoxicillin 1.0 g tid for 14 days RAB Bismuth potassium citrate Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, and Amoxicillin 1.0 g tid for 14 days RBAM Bismuth potassium citrate Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days RBLM Bismuth potassium citrate Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levofloxacin 0.5 g bid for 14 days RBCM Bismuth potassium citrate Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days RAM Metronidazole Rabeprazole 20 mg bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days RBTM Bismuth potassium citrate Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and tetracycline 0.5 g qid for 14 days RAM Amoxicillin Rabeprazole 20 mg bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days RBDM Rabeprazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days RBCL Rabeprazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levofloxacin 0.5 g qd for 14 days RBLM Rabeprazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levofloxacin 0.5 g bid for 14 days RBCL Clarithromycin Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levofloxacin 0.5 g qd for 14 days RBCL Levofloxacin Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, clarithromycin 0.5 g bid and levofloxacin 0.5 g qd for 14 days RBLM Metronidazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levofloxacin 0.5 g bid for 14 days RBLM Levofloxacin Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and levofloxacin 0.5 g bid for 14 days RBCM Rabeprazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days RBCM Metronidazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days RBCM Clarithromycin Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and clarithromycin 0.5 g bid for 14 days RA Amoxicillin Rabeprazole 20 mg bid, and Amoxicillin 1.0 g tid for 14 days RAB Rabeprazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, and Amoxicillin 1.0 g tid for 14 days RAB Amoxicillin Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, and Amoxicillin 1.0 g tid for 14 days RAM Rabeprazole Rabeprazole 20 mg bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days RBAM Rabeprazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days RBAM4 Rabeprazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g tid for 14 days RBAM Amoxicillin Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g tid, and Amoxicillin 1.0 g tid for 14 days RBAM4 Amoxicillin Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g tid for 14 days RBAM4 Metronidazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and Amoxicillin 1.0 g tid for 14 days RBDM Doxycycline Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days RBDM Metronidazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days RBTM Rabeprazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and tetracycline 0.5 g qid for 14 days RBTM Metronidazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and tetracycline 0.5 g qid for 14 days RBTM Tetracycline Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid, and tetracycline 0.5 g qid for 14 days
- Primary Outcome Measures
Name Time Method Eradication rate of Helicobacter pylori 6 weeks Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value).
- Secondary Outcome Measures
Name Time Method Eradication rate of Helicobacter pylori susceptible strains 6 weeks Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value). The antibiotic susceptible strains were assessed using the E test method.
Eradication rate of Helicobacter pylori resistant strains 6 weeks Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value). The antibiotic resistant strains were assessed using the E test method.
Trial Locations
- Locations (1)
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China