Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 307
Healthy volunteers: no

Brief summary:
To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected patients were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter pylori eradication rates between three groups.

Detailed description:
The purpose of this study is to compare the effectiveness of three H. pylori eradication regimens: 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) and 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days) in Taiwan.

A total of 306 subjects are enrolled into this study.

H. pylori-infected patients are randomized to a 7-day standard triple therapy, a 10-day sequential therapy, or a 7-day quadruple therapy. Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the H. pylori therapy. The eradication rates of three groups will be compared.

Arms:
arm 1: 1. pantoprazole 40 mg twice daily for 7 days,
2. clarithromycin 500 mg twice daily for 7 days,
3. amoxicillin 1 g twice daily for 7 days,
4. metronidazole 500 mg twice daily for 7 days arm 2: 1. pantoprazole 40 mg twice daily for 5 days and amoxicillin 1 g twice daily for 5 days, followed by
2. pantoprazole 40 mg twice daily for 5 days, clarithromycin 500 mg twice daily for 5 days, metronidazole 500 mg twice daily for 5 days. arm 3: 1. pantoprazole 40 mg twice daily for 7 days,
2. clarithromycin 500 mg twice daily for 7 days,
3. amoxicillin 1 g twice daily for 7 days.

Interventions: intervention 1: 7-day quadruple therapy intervention 2: 10-day sequential therapy intervention 3: 7-day standard triple therapy
Intervention descriptions: intervention 1: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days intervention 2: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days intervention 3: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days

Protocol document: