Clinical Trial: Eradication Rates of Helicobacter Pylori and Its Affecting Factors

Study Status: Completed
Recruit Status: Completed
Study Type: Observational [Patient Registry]

Official Title: The Trend of Eradication Rates of First-line Triple Therapy for Helicobacter Pylori and Clinical Factors That Affect the Eradication in Korean: Single Center Experience for Recent Ten Years

Brief Summary: The purpose of this study is to investigate the trend of eradication rates of first-line triple therapy for Helicobacter pylori in recent ten years and clinical factors that affect the eradication in Korean.

Detailed Summary: A PPI triple regimen combining a proton pump inhibitor(PPI) with two antibiotics (amoxicillin and clarithromycin) is currently considered the gold standard therapy for eradication of H. pylori. However, recently the eradication rate with first-line treatment has a tendency to decrease because of increasing antibiotics resistance. In addition, PPI is mainly metabolized by cytochrome p450 2C19 (CYP2C19) in the liver and several reports have suggested that differences in th CYP2C19 genotype are associated with H. pylori eradication failure. Thus, the first aim of this study is to investigate the trend of eradication rates of first-line triple therapy in recent ten years. And the second aim is to analyze the antibiotics resistance rate for H. pylori by using culture minimal inhibitory concentrations(MICs) result and to analyze the association between CYP2C19 genotype and eradication rate of H.pylori. And also investigate the other clinical factors (age, gender, underlying disease, cigarette smoking and alcohol use) that affect the eradication rate.
Sponsor: Seoul National University Bundang Hospital

Current Primary Outcome: Eradication Rates of First-line Triple Therapy for Helicobacter pylori [ Time Frame: Four weeks after completing eradication therapy ]

Non invasive H. pylori test (13C-urea breath test(UBT)) or invasive H. pylori test (Giemsa histology, Rapid Urease test) were performed after four weeks after completing eradication therapy.


Original Primary Outcome: Same as current

Current Secondary Outcome: Clinical Factors that Affect the Eradication [ Time Frame: Four weeks after completing eradication therapy ]

Main variables are Cytochrome P450 2C19 (CYP2C19) genotype and Antibiotics resistance by H. pylori culture MICs result.

Other variables are age, gender, underlying disease (hypertension, diabetes, chronic liver, lung, kidney diseases), cigarette smoking and alcohol use.



Original Secondary Outcome: Same as current

Information By: Seoul National University Bundang Hospital

Dates:
Date Received: August 11, 2013
Date Started: January 2003
Date Completion:
Last Updated: August 11, 2013
Last Verified: August 2013