Helicobacter Pylori Antibiotic Susceptibility Testing of Korea

Lymphoma Clinical Trial

Official title:

Helicobacter Pylori Antibiotic Susceptibility Testing of Korea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02961296
• Other study ID #: AMC 2016-0467
• Status: Not yet recruiting
• Phase: N/A
• First received: October 26, 2016
• Last updated: November 8, 2016
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: Asan Medical Center
• Contact: Hwoon-Yong Jung, M.D., Ph.D.
• Email: hyjung[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 79 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Disease Susceptibility
• Gastric Cancer
• Gastritis
• Helicobacter Infections
• Helicobacter Pylori Infection
• Lymphoma
• Peptic Ulcer
• Stomach Neoplasms

Intervention

Other:
• No intervention
No intervention will be needed.

Locations

Country	Name	City	State
Korea, Republic of	Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	National Evidence-Based Healthcare Collaborating Agency

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The gap of the rate of the antibiotic resistance to H. pylori by regional groups		6 more days	No
Secondary	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	No