High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT04024527
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief Summary
Dual therapy containing high dose of proton pump inhibitor (PPI) and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined the the efficacy of high dose of dual therapy or dual therapy plus metronidazole for H. pylori rescue treatment.This study is designed to evaluate the efficacy and safety of the addition of metronidazole to high dose of dual therapy for H. pylori rescue treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 306
- 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 previous treatment failure
- Less than 18 years old or older than 80 years
- 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 Dual therapy Amoxicillin Esomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days Metronidazole plus dual therapy Metronidazole Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days Dual therapy Esomeprazole Esomeprazole 40mg bid and Amoxicillin 1.0g tid for 14 days Metronidazole plus dual therapy Esomeprazole Esomeprazole 40mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days Metronidazole plus dual therapy Amoxicillin Esomeprazole 40mg 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