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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
Sponsor:
Collaborator:
National Evidence-Based Healthcare Collaborating Agency
Information provided by (Responsible Party):
Hwoon-Yong Jung, 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.

Condition or disease Intervention/treatment
Helicobacter Pylori Infection Peptic Ulcer Lymphoma Gastric Cancer Gastritis Other: No intervention

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics


Intervention Details:
  • Other: No intervention
    No intervention will be needed.


Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. The gap of the rate of the antibiotic resistance to H. pylori by regional groups [ Time Frame: 6 more days ]
  2. 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
Mucosa on the antrum and body of the stomach.


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The subjects required to the examination of Helicobacter pylori infection is necessary during upper gastrointestinal endoscopy due to peptic ulcer, lymphoma, gastric cancer, gastritis, et al.
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Hwoon-Yong Jung, M.D., Ph.D. hyjung@amc.seoul.kr
Contact: Ji Yong Ahn, M.D., Ph.D. ji110@hanmail.net

Locations
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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.       ji110@hanmail.net   
Sponsors and Collaborators
Asan Medical Center
National Evidence-Based Healthcare Collaborating Agency
Investigators
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Principal Investigator: Hwoon-Yong Jung, Professor Asan Medical Center

Additional Information:

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Responsible Party: Hwoon-Yong Jung, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02961296     History of Changes
Other Study ID Numbers: AMC 2016-0467
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hwoon-Yong Jung, Asan Medical Center:
Helicobacter Pylori

Additional relevant MeSH terms:
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Disease Susceptibility
Anti-Bacterial Agents
Anti-Infective Agents
Helicobacter Infections
Peptic Ulcer
Gastritis
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Disease Attributes
Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections
Duodenal Diseases
Intestinal Diseases
Gastroenteritis