Helicobacter Pylori Infection Clinical Trial
Official title:
Comparison of the Efficacy of 14-day Sequential Therapy and 10-day Bismuth Quadruple Therapy in the Second Line Therapy for Helicobacter Pylori Infection: A Multi-center Randomized Trial
Objectives: A recent randomized trial showed that 14-day sequential therapy containing high dose proton pump inhibitor was higher than 95% in the first line treatment. However, whether the 14-day sequential therapy is more effective than 10-day bismuth quadruple therapy remains unknown. Therefore, the investigators aimed to compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the second line treatment.
This will be a multi-center, open labeled, randomized comparative trial Patients: 240
patients with H. pylori infection who failed after first-line therapy will be eligible
Interventions: eligible patients will be randomized into one of the two groups Group (A):
sequential therapy for 14 days (S14)
D1-D7: (esomeprazole 40mg bid + amoxicillin 1000mg bid) for 7 days
D8-D14: (esomeprazole 40mg bid + clarithromycin 500mg bid + metronidazole 500mg bid) for
another 7 days
Group (B): bismuth quadruple therapy for 10 days (Q10)
D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid +
tetracycline 500mg qid) for 10 days
Primary End Point: Eradication rate in the second line treatment according to intention to
treat (ITT) analysis in the two treatment groups
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