Helicobacter Pylori Infection Clinical Trial
Official title:
Comparison Between Ten Days Sequential Treatment (With Metronidazole or Tetracycline) and Ten Days Standard Triple Therapy of Helicobacter Pylori
The purpose of this study is to compare the eradication efficacy of 10-day triple therapy with 10-day sequential therapy with tetracycline or metronidazole.
Background: Antimicrobial resistance has decreased eradication rates for Helicobacter pylori
infection worldwide.
Objective: To determine whether sequential treatment eradicates H. pylori infection better
than standard triple-drug therapy for adults with dyspepsia or peptic ulcers in Taiwanese
people.
Design: Randomized, single-blind, prospective controlled trial. Setting: A large tertiary
referral hospital in eastern Taiwan. Patients: 450 patients with dyspepsia or peptic ulcers
and infected by H. 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: 450 patients with H. pylori infection are randomly assigned to receive one of
the following therapeutic schemes: group A (5RA5RCT): rabeprazole (20 mg bid) plus
amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus clarithromycin
(500 mg bid) and tetracycline (1g bid) for a further 5 days; group B (5RA5RCM): rabeprazole
(20 mg bid) plus amoxicillin (1 g bid) for 5 days, followed by rabeprazole (20 mg bid) plus
clarithromycin (500 mg bid) and metronidazole (500mg bid) for a further 5 days; group C as
control: rabeprazole (20 mg bid) plus amoxicillin (1 g bid) and clarithromycin (500 mg bid.)
for 10 days.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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