Eradication Rates of Helicobacter Pylori and Its Affecting Factors

N/ACompletedNCT01922505

Seoul National University Bundang Hospital2,500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

2,500

Conditions

Helicobacter Infections

Interventions

PPI triple therapyDRUG

Eligibility

Sex: ALLMin age: 16 YearsMax age: 92 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who proven H. pylori infection by invasive or non-invasive H. pylori test * Patients treated with First-line triple therapy (PPI + Amoxicillin + Clarithromycin) Exclusion Criteria: * Previous eradication therapy for H. pylori * Follow-up loss patients after eradication therapy * Other treatment regimen * Poor medication compliance (\<80%)

Locations (1)

Seoul National University Bundang Hospital

Bundang-gu, Seongnam, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Eradication Rates of First-line Triple Therapy for Helicobacter pylori

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.

Time frame: Four weeks after completing eradication therapy

Secondary Outcomes

Clinical Factors that Affect the Eradication

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.

Time frame: Four weeks after completing eradication therapy

Data from ClinicalTrials.gov

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