Helicobacter Pylori Infection Clinical Trial
Official title:
Comparison of Bismuth Containing Quadruple Therapy and Clarithromycin Susceptibility-based Tailored Therapy for Helicobacter Pylori First-line Eradication
As the antibiotic resistance increases, the eradication rate of triple therapy is decreasing. Recent guideline recommend the use of bismuth-containing quadruple therapy in areas where clarithromycin resistance is greater than 15%. However, the ideal treatment would be the tailored therapy which choose the antibiotics depending on the antibiotic resistance. This study compared the eradication rates, safety and complicance of tailored therapy compared with empirical bismuth quadruple therapy in the naive patients with H. pylori infection.
In order to be eligible for first-line H. pylori eradication therapy, at least 80% of
eradication rate should be achieved by intention to treat (ITT) analysis. However, the triple
therapy (PPI, clarithromycin, amoxicillin) is losing 1st-line therapy because of increasing
antibiotic resistance. The most common cause of failure in triple therapy is clarithromycin
resistance.
In the past, clarithromycin resistance was rarely observed in Korea, but the resistance rate
has increased rapidly during the last 10 years, up to 37.3%.
As an alternative, Korean guidelines of Helicobacter pylori eradication in 2013 recommend
that bismuth-containing antibiotics (not containing clarithromycin) should be considered in
areas with high clarithromycin resistance as in Korea. However, there is a lack of research
on the efficacy of bismuth-containing quadruple therapy as a 1st-line therapy. The aim of
this prospectivce randomized study is to investingate the efficacy, conpliance, adverse
events and cost-effectiveness between bismuth containing quadruple therapy and tailored
therapy in areas with high clarithromycin resistance
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