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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
390
Pantoprazole 40mg bid
Amoxicillin 1000mg bid
Clarithromycin 500mg bid
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Counts of Participants With Successful H. Pylori Eradication
Time frame: 4 weeks after termination of eradication therapy, up to 6 weeks
Counts of Participants Whose Drug Compliance is More Than 85%
Time frame: 4 weeks after termination of eradication therapy, up to 6 weeks
Counts of Participants With Adverse Event
Time frame: 4 weeks after termination of eradication therapy, up to 6 weeks
Functional Dyspepsia Symptom Responses Rate
Time frame: 1 year after termination of eradication therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Metronidazole 500mg tid
Tetracycline 1000mg bid
Bismuth 600mg bid