Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 390
Healthy volunteers: no

Brief summary:
1. To compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.
2. To evaluate the effect of H. pylori eradication therapy on the symptom improvement of functional dyspepsia

Detailed description:
Emerging evidence shows that the eradication rate of proton pump inhibitor (PPI)-based triple therapy for the first-line treatment of Helicobacter pylori has decreased. The reason for the decrease in the efficacy of PPI-based triple therapy is mainly due to the increase in the resistance against clarithromycin. Sequential therapy seems to be more effective than the PPI-based triple therapy, however, the eradication rate of sequential therapy in Korea, which is mostly under 80%, is still not satisfactory. Modified bismuth quadruple therapy which replace metronidazole with amoxicillin (contained PPI, bismuth, tetracycline and amoxicillin) can be a promising regimen because the antibiotic resistance rate of tetracycline and amoxicillin are relatively low in Korea and amoxicillin is more easy to take in comparing with metronidazole. Therefore, the aim of this study is to compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.

In addition, previous studies reported that H. pylori infection also associated with functional dyspepsia (FD) and recommended H. pylori eradication in patients with FD. However, until now, there was no randomized prospective study in Korea, therefore the another aim of this study is to evaluate the effect of H. pylori eradication therapy on the symptom improvement of FD.

Arms:
arm 1: pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10) arm 2: pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)

Interventions: intervention 1: Pantoprazole intervention 2: Amoxicillin intervention 3: Clarithromycin intervention 4: Metronidazole intervention 5: Tetracycline intervention 6: Bismuth
Intervention descriptions: intervention 1: Pantoprazole 40mg bid intervention 2: Amoxicillin 1000mg bid intervention 3: Clarithromycin 500mg bid intervention 4: Metronidazole 500mg tid intervention 5: Tetracycline 1000mg bid intervention 6: Bismuth 600mg bid

Protocol document: