Whether non-bismuth quadruple therapy (concomitant therapy) is more effective than bismuth quadruple therapy or triple therapy for 14 days remains unknown. Therefore, we aim to compare the eradication rates and long term re-infection rates of quadruple therapy for 10 days versus non-bismuth quadruple therapy for 10 days vs. triple therapy for 14 days. Methods: This will be a multi-center, open labeled, randomized control trial Patients: H. pylori infected patients who have willingness to receive eradication therapy Testing for H. pylori infection Before First Line Ttreatment (1)Any two positive of rapid urease test, histology, serology and culture or a positive UBT will be considered as H. pylori infected After First Line Treatment: C13-Urea breath test will be used to assess the existence of H. pylori 6-8 weeks after first line therapy. Long term reinfection: C13- Urea breath test will be used to assess the recurrence of H. pylori 1 year after eradication therapy
First line therapy: open labeled, randomized control trial, randomized into one of the three groups Group (A): triple therapy for 14 days D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid Group (B): non-bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + amoxicillin 1gm bid + clarithromycin 500mg bid + metronidazole 500mg bid Group (C): bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + colloidal bismuth subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid Second line therapy: patients who fail from first line treatment will be rescue with the following treatment Group (A) Patient who fail from triple therapy will be retreated with bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + colloidal bismuth subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid Group (B) Patient who fail from non-bismuth quadruple therapy will be retreated with bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + colloidal bismuth subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid Group (C) Patients who fail from bismuth quadruple therapy will be retreated with non-bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + amoxicillin 1gm bid + clarithromycin 500mg bid + metronidazole 500mg bid
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,620
triple therapy, quadruple therapy, non-bismuth quadruple therapy
Chiayi Christian Hospital
Chiayi City, Taiwan
RECRUITINGNational Taiwan University Hospital, Hsinchu Branch
Hsinchu, Taiwan
RECRUITINGE- DA Hospital and I-Shou University
Kaohsiung City, Taiwan
RECRUITINGKaohsiung Medical University Hospital
Kaohsiung City, Taiwan
RECRUITINGMing-Shiang Wu
Taipei, Taiwan
RECRUITINGMackay Memorial Hospital, Taipei
Taipei, Taiwan
RECRUITINGTaipei Medical University Hospital
Taipei, Taiwan
RECRUITINGTaipei Veterans General Hospital
Taipei, Taiwan
RECRUITINGMackay Memorial Hospital, Taitung
Taitung, Taiwan
RECRUITINGNational Taiwan University Hospital, Yun-Lin Branch
Yun-Lin County, Taiwan
RECRUITINGEradication rate for H. pylori
Eradication rate in the first line according to intention to treat (ITT) and per-protocol (PP) analysis in the three treatment groups
Time frame: 6 weeks
Adverse effects of each treatments
(1) Incidence of adverse effects in the first line therapy in the three treatment groups
Time frame: 2 weeks
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