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Helicobacter Pylori Antibiotic Susceptibility Testing of Korea

Helicobacter Pylori Antibiotic Susceptibility Testing of Korea

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02961296
Enrollment
400
Registered
2016-11-10
Start date
2016-10-31
Completion date
2018-12-31
Last updated
2016-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Helicobacter Pylori

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.

Interventions

OTHERNo intervention

No intervention will be needed.

Sponsors

National Evidence-Based Healthcare Collaborating Agency
CollaboratorOTHER_GOV
Asan Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The rate of exceeding the resistance criteria in Helicobacter pylori(H. pylori) antibiotic susceptibility test(Agar dilution method)6 more daysThe 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

MeasureTime frameDescription
The gap of the rate of the antibiotic resistance to H. pylori by regional groups6 more days
The success rate of H. pylori strain separation6 more daysAnalyze the case of inseparable H. pylori strain and the reason of failure for culture after H. pylori strain separation.

Countries

South Korea

Contacts

Primary ContactHwoon-Yong Jung, M.D., Ph.D.
hyjung@amc.seoul.kr
Backup ContactJi Yong Ahn, M.D., Ph.D.
ji110@hanmail.net

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026