Helicobacter Pylori Antibiotic Susceptibility Testing of Korea

• Conditions: Helicobacter Pylori Infection; Gastritis; Peptic Ulcer; Gastric Cancer; Lymphoma

• Registration Number: NCT02961296
• Lead Sponsor: Asan Medical Center

Brief Summary

The purpose of this study is to make nationwide registry for antimicrobial resistance of Helicobacter pylori using single method with agar dilution in Korea.

Detailed Description

Backgrounds:

The success rate of Helicobacter pylori eradication in Korea is not sufficient in recent days. The main cause of eradication failure is known as antimicrobial resistance and previous studies showed that resistant rates were different according to the regions in Korea. However, until now, there are not enough studies about the nationwide results for antimicrobial resistance and previous reports used various methods for the resistant test.

Theories and Plans:

The nationwide resistant registry of Helicobacter pylori using standardized single method, agar dilution test, can be useful for the development of new eradication methods to make eradication rate higher. Moreover, the higher rate of Helicobacter pylori eradication can reduce the chance of gastric cancer and also can reduce the medical expenses.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-26
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-08
• Last Update Submitted: 2016-11-08
• Study First Posted: 2016-11-10
• Last Update Posted: 2016-11-10
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Aged 19 to 79 year person who need the examination of Helicobacter pylori infection during upper gastrointestinal endoscopy.
• No history of Helicobacter pylori eradication.
• No history of antibiotics within one month.
• Person who agree on the consent.

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Exclusion Criteria

• History of antibiotics more than 3 days sequentially within one month.
• History of subtotal gastrectomy.
• Person who does not agree on the consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of exceeding the resistance criteria in Helicobacter pylori(H. pylori) antibiotic susceptibility test(Agar dilution method)	6 more days	The resistance criterion specifies that Clarithromycin is excess of 1.0 μg/mL, Amoxicillin is excess of 0.5 μg/mL, Metronidazole is excess of 8 μg/mL, Tetracycline is excess of 4 μg/mL, Levofloxacin is excess of 1 μg/mL and Ciprofloxacin is excess of 1 μg/mL.; All of resistance criteria follow a criteria of NCCLS(National Committee for Clinical Laboratory Standards)

Secondary Outcome Measures

Name	Time	Method
The success rate of H. pylori strain separation	6 more days	Analyze the case of inseparable H. pylori strain and the reason of failure for culture after H. pylori strain separation.
The gap of the rate of the antibiotic resistance to H. pylori by regional groups	6 more days

Trial Locations

Locations (1)

Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of