Helicobacter Pylori Infection Clinical Trial
Official title:
A Prospective, Multi-center, Randomized, Open-label, Parallel Design Clinical Trial to Compare 10-day Sequential Therapy and 14-day Modified Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea
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.
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