Eradication Rates of Helicobacter Pylori and Its Affecting Factors

Helicobacter Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922505
• Other study ID #: B-1308-214-108
• Secondary ID: 2012R1A1A3A04002
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2013
• Last updated: August 11, 2013
• Start date: January 2003
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 92 Years

Eligibility

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%)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Helicobacter Infections

Intervention

Drug:
• PPI triple therapy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Bundang-gu, Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Four weeks after completing eradication therapy	Yes
Secondary	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.	Four weeks after completing eradication therapy	No