High Dose of Amoxicillin and Metronidazole Plus Bismuth For Helicobacter Pylori Treatment
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT03557437
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief Summary
Amoxicillin and metronidazole （400mg Q.D.S） based quadruple therapy had achieved a high cure rate in the rescue treatment of helicobacter pylori infection. This study aims to evaluate the efficacy and safety of the amoxicillin and metronidazole (400mg thrice a day) based triple therapy and the addition of bismuth in the naive patients with helicobacter pylori infection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 216
- Participants with non-ulcer functional dyspepsia or peptic ulcer disease
- Ability and willingness to participate in the study and to sign and give informed consent
- Confirmed H. pylori infection and with no previous treatment experience
- Less than 18 years old
- 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 Bismuth Plus Triple Therapy Amoxicillin, Metronidazole Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days Triple Therapy Esomeprazole Esomeprazole 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days Triple Therapy Amoxicillin, Metronidazole Esomeprazole 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days Bismuth Plus Triple Therapy Bismuth Potassium Citrate Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days Bismuth Plus Triple Therapy Esomeprazole Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
- Primary Outcome Measures
Name Time Method Helicobacter pylori eradication rate Six weeks after completion of therapy Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).
- Secondary Outcome Measures
Name Time Method Rate of adverse effects Within 7 days after completion of therapy The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities)
Compliance rate Within 7 days after completion of therapy Compliance was defined as poor when they had taken less than 80% of the total medication
Trial Locations
- Locations (1)
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China