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Eradication Rates of Helicobacter Pylori and Its Affecting Factors

NCT ID: NCT01922505

Last Updated: 2013-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Helicobacter Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

PPI triple therapy

Intervention Type DRUG

Interventions

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PPI triple therapy

Intervention Type DRUG

Eligibility Criteria

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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%)
Minimum Eligible Age

16 Years

Maximum Eligible Age

92 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nayoung Kim

Professor, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

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

Site Status

Countries

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South Korea

Other Identifiers

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2012R1A1A3A04002680

Identifier Type: OTHER

Identifier Source: secondary_id

B-1308-214-108

Identifier Type: -

Identifier Source: org_study_id