Tetracycline Versus Doxycycline for HP Rescue Therapy
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT05018923
- Lead Sponsor
- Shanghai Zhongshan Hospital
- Brief Summary
This randomized controlled clinical trial will evaluate the efficacy and safety of proton pump inhibitor, bismuth, metronidazole, and either tetracycline or doxycycline for Helicobacter pylori rescue treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 242
- 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.
- Have failed eradication treatment before.
- Have not received Hp eradication treatment.
- 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, PPI 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 RAMT group 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 RBMD group 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 RBMD group 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 RAMT group 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 RBMD group 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 RBMD group 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 RAMT group 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 RAMT group 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
- Primary Outcome Measures
Name Time Method Eradication rate of Helicobacter pylori At least 4 weeks after completion of therapy 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 resistant strains At least 4 weeks after completion of therapy 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.
Eradication rate of Helicobacter pylori susceptible strains At least 4 weeks after completion of therapy 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.
Trial Locations
- Locations (1)
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China