Helicobacter Pylori Antibiotic Susceptibility Testing of Korea
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|ClinicalTrials.gov Identifier: NCT02961296|
Recruitment Status : Unknown
Verified November 2016 by Hwoon-Yong Jung, Asan Medical Center.
Recruitment status was: Not yet recruiting
First Posted : November 10, 2016
Last Update Posted : November 10, 2016
|Condition or disease||Intervention/treatment|
|Helicobacter Pylori Infection Peptic Ulcer Lymphoma Gastric Cancer Gastritis||Other: No intervention|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||400 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Helicobacter Pylori Antibiotic Susceptibility Testing of Korea|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
- Other: No intervention
No intervention will be needed.
- The rate of exceeding the resistance criteria in Helicobacter pylori(H. pylori) antibiotic susceptibility test(Agar dilution method) [ Time Frame: 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)
- The gap of the rate of the antibiotic resistance to H. pylori by regional groups [ Time Frame: 6 more days ]
- The success rate of H. pylori strain separation [ Time Frame: 6 more days ]Analyze the case of inseparable H. pylori strain and the reason of failure for culture after H. pylori strain separation.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961296
|Contact: Hwoon-Yong Jung, M.D., Ph.D.||email@example.com|
|Contact: Ji Yong Ahn, M.D., Ph.D.||firstname.lastname@example.org|
|Korea, Republic of|
|Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center||Not yet recruiting|
|Seoul, Korea, Republic of, 05505|
|Contact: Ji Yong Ahn, M.D., Ph.D. email@example.com|
|Principal Investigator:||Hwoon-Yong Jung, Professor||Asan Medical Center|