Eradication Rates of Helicobacter Pylori and Its Affecting Factors

Completed

• Conditions: Helicobacter Infections
• Interventions: Drug: PPI triple therapy

• Registration Number: NCT01922505
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-08
• Study First Submitted: 2013-08-11
• Study First Submitted QC: 2013-08-11
• Last Update Submitted: 2013-08-11
• Study First Posted: 2013-08-14
• Last Update Posted: 2013-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2500

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)

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Exclusion Criteria

• Previous eradication therapy for H. pylori
• Follow-up loss patients after eradication therapy
• Other treatment regimen
• Poor medication compliance (<80%)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PPI triple therapy	PPI triple therapy	7-day PPI triple therapy regimen: PPI (esomeprazole 40 mg or omeprazole 20 mg or lansoprazole 30 mg or pantoprazole 40 mg or rabeprazole 20 mg) plus amoxicillin (1000mg) and clarithromycin (500mg) twice daily for 7 days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Bundang-gu, Seongnam, Gyeonggi-do, Korea, Republic of