Eradication Rates of Helicobacter Pylori and Its Affecting Factors

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01922505

Enrollment

2500

Registered

2013-08-14

Start date

2003-01-31

Completion date

2013-05-31

Last updated

2013-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Infections

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 description

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.

Interventions

DRUGPPI triple therapy

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 92 Years

Healthy volunteers

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%)

Design outcomes

Primary

Measure	Time frame	Description
Eradication Rates of First-line Triple Therapy for Helicobacter pylori	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.

Secondary

Measure	Time frame	Description
Clinical Factors that Affect the Eradication	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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026