Helicobacter Pylori Antibiotic Susceptibility Testing of Korea

Study Overview
=================
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.

Official Title
-----------------
Helicobacter Pylori Antibiotic Susceptibility Testing of Korea

Conditions
-----------------
Helicobacter Pylori Infection, Peptic Ulcer, Lymphoma, Gastric Cancer, Gastritis

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention will be needed.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of exceeding the resistance criteria in Helicobacter pylori(H. pylori) antibiotic susceptibility test(Agar dilution method) | 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) | 6 more days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The gap of the rate of the antibiotic resistance to H. pylori by regional groups |  | 6 more days | 
| The success rate of H. pylori strain separation | Analyze the case of inseparable H. pylori strain and the reason of failure for culture after H. pylori strain separation. | 6 more days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter Pylori