Rescue Therapy for Helicobacter Pylori Eradication Treatment
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Drug: Tetracycline,MetronidazoleDrug: Minocycline,Metronidazole
- Registration Number
- NCT04531059
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief Summary
Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by minocycline.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 368
- Ability and willingness to participate in the study and to sign and give informed consent
- Confirmed H. pylori infection and with previous treatment failure
- subjects naive to H. pylori treatment,
- under 18 or over 80 years old
- history of gastrectomy
- pregnant or lactating women
- severe systemic diseases or malignancy
- administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
- contraindications to the study drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tetracycline Bismuth Quadruple Therapy Esomeprazole Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Tetracycline 500mg qid Metronidazole 400mg qid Tetracycline Bismuth Quadruple Therapy Bismuth Potassium Citrate Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Tetracycline 500mg qid Metronidazole 400mg qid Tetracycline Bismuth Quadruple Therapy Tetracycline,Metronidazole Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Tetracycline 500mg qid Metronidazole 400mg qid Minocycline Bismuth Quadruple Therapy Esomeprazole Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Minocycline 100mg bid Metronidazole 400mg qid Minocycline Bismuth Quadruple Therapy Bismuth Potassium Citrate Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Minocycline 100mg bid Metronidazole 400mg qid Minocycline Bismuth Quadruple Therapy Minocycline,Metronidazole Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Minocycline 100mg bid Metronidazole 400mg qid
- 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 (3)
Shanghai East Hospital, Tongji University School of Medicine
🇨🇳Shanghai, Shanghai, China
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China
The Second Affiliated Hospital of Zhejiang University school of Medicine
🇨🇳Hangzhou, Zhejiang, China