Skip to main content
OpenTrials
Completed

NCT Number: NCT01922505

Eradication Rates of Helicobacter Pylori and Its Affecting Factors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Helicobacter Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections

Age range

16 year–92 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Bundang-gu, Seongnam, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

PPI triple therapy

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2013
Study completion
2013
First posted
Aug 14, 2013
Registry last updated
Aug 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.