Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment
Phase 4
Completed
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT02732249
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief Summary
Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical first-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
- Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease
- Ability and willingness to participate in the study and to sign and give informed consent
- confirmed H. pylori infection
Exclusion Criteria
- Previous H. pylori eradication therapy
- Less than 18 years old
- With history of H. pylori infection treatment
- With previous gastric surgery
- Major systemic diseases
- Pregnancy or lactation
- Allergy to any of the study drugs
- Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low metronidazole group Esomeprazole Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days Triple regimen group Esomeprazole Esomeprazole 20mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days Triple regimen group Clarithromycin Esomeprazole 20mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days Low metronidazole group Bismuth Potassium Citrate Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days Low metronidazole group Clarithromycin Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days High metronidazole group Bismuth Potassium Citrate Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days Triple regimen group Metronidazole Esomeprazole 20mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days High metronidazole group Esomeprazole Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days Low metronidazole group Metronidazole Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg bid for 14 days High metronidazole group Clarithromycin Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days High metronidazole group Metronidazole Esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, clarithromycin 500mg bid and metronidazole 400mg qid for 14 days
- Primary Outcome Measures
Name Time Method Helicobacter pylori eradication rate Six weeks after completion of therapy
- Secondary Outcome Measures
Name Time Method Rate of adverse effects within 7 days after completion of therapy Compliance rate within 7 days after completion of therapy
Trial Locations
- Locations (1)
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China