Bismuth-Metronidazole Triple Therapy for H. Pylori First-line Treatment
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT04667299
- Lead Sponsor
- Shanghai Zhongshan Hospital
- Brief Summary
This randomized controlled clinical trial will compare the eradication efficacy of bismuth-metronidazole triple therapy (PPI+bismuth+ metronidazole) with that of bismuth-metronidazole quadruple therapy (PPI+bismuth+ metronidazole+ amoxicillin) for Helicobacter pylori first-line 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
- UNKNOWN
- Sex
- All
- Target Recruitment
- 270
- 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 not received Helicobacter pylori eradication treatment before.
- Have 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 BMQ group Bismuth potassium citrate Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and amoxicillin 1 g bid for 14 days BMT group Bismuth potassium citrate Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid and metronidazole 0.4 g qid for 14 days BMT group Rabeprazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid and metronidazole 0.4 g qid for 14 days BMQ group Rabeprazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and amoxicillin 1 g bid for 14 days BMT group Metronidazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid and metronidazole 0.4 g qid for 14 days BMQ group Amoxicillin Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and amoxicillin 1 g bid for 14 days BMQ group Metronidazole Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and amoxicillin 1 g bid 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 metronidazole-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 strains with minimal inhibitory concentration (MIC) value of metronidazole \>8 μg/ml were defined as resistant strains.
Eradication rate of Helicobacter pylori metronidazole-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 strains with metronidazole MIC value \<=8 μg/ml were defined as susceptible strains.
Trial Locations
- Locations (1)
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China