Helicobacter Pylori Infection Clinical Trial
Official title:
Rabeprazole Based Sequential-Concommitant Hybrid Therapies for H. Pylori Infections
This prospective controlled randomized open-label clinical trial is designed to determine the optimal eradication rate of rabeprazole based sequential-concommitant hybrid therapies for adults infected with Helicobacter pylori in Eastern Taiwan. Enrolled patients will receive 3, 5 or 7 days of pre-concommitant (sequential part) treatment with rabeprazole + amoxicillin, then 7 days of concommitant treatment with rabeprazole + amoxicillin + clarithromycin + metronidazole.
Background: Antimicrobial resistance has decreased the worldwide eradication rates of common
used triple therapy for Helicobacter pylori infection (less than 80%).
Objective: To determine the optimal pre-concommitant treatment length for rabeprazole based
sequential-concomitant hybrid therapies for adults infected with Helicobacter pylori in
Eastern Taiwan.
Design: Randomized, open-label, prospective controlled trial.
Patients: 231 patients with dyspepsia or peptic ulcers and infected by Helicobacter pylori.
Measurements: 13C-urea breath test, upper endoscopy, histologic evaluation, rapid urease
test, bacterial culture, assessment of antibiotic resistance and CYP2C19 genotype of host.
Intervention: 231 patients with Helicobacter pylori infection are recruited and randomly
assigned to receive one of the following therapeutic schemes: group 1, 14-days hybrid
therapy: rabeprazole 20mg bid + amoxicillin 1g bid treated for 7 days, then rabeprazole 20mg
bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7
days; group 2, 12-days hybrid therapy: rabeprazole 20mg bid + amoxicillin 1g bid treated for
5 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid +
metronidazole 0.5g bid for other 7 days; group 3, 10-days hybrid therapy: rabeprazole 20mg
bid + amoxicillin 1g bid treated for 3 days, then rabeprazole 20mg bid + amoxicillin 1g bid
+ clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days. Repeat upper endoscopy
for histologic evaluation, rapid urease test or 13C-urea breath test after 4 week of
treatment to assess the treatment result. The influence on the hybrid therapies of
antibiotic resistance of Helicobacter pylori and CYP2C19 genotype of host were determined.
Expected results: The rabeprazole based sequential-concomitant therapies for eradication of
Helicobacter pylori is very effective, and the outcome is not affected by antibiotic
resistance of Helicobacter pylori and CYP2C19 genotype of host.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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