Eradication Rates of Helicobacter Pylori and Its Affecting Factors

Seoul National University

Status: Completed

Conditions: Helicobacter Infections

Treatments: Drug: PPI triple therapy

Study type: Observational

Funder types: Other

Identifiers

NCT01922505

B-1308-214-108

2012R1A1A3A04002680 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 patients

Sex: All

Ages: 16 to 92 years old

Volunteers: No 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%)

Trial design

2,500 participants in 1 patient group

PPI triple therapy

Description:

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.

Treatment:

Drug: PPI triple therapy