rabeprazole based sequential-concommitant hybrid therapies for h. pylori infections

Conditions: Helicobacter Pylori Infection

Summary: 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.

Eligibility criteria:
inclusion criteria: * patient proved with infection of h. pylori in gastric mucosa (at least two of four tests positive) exclusion criteria: * woman in breast feeding or pregnancy. * allergy to drugs used in study. * previously treated for h. pylori. * intolerance to fructose, lactose. * patients with hematologic, brain or spinal disorders * patients under 20 years old * patients under aspirin or clopidogrel * patients with history of gastric cancer or gastric resection operation.

Keywords: helicobacter pylori antibiotic resistance sequential-concomitant hybrid therapy