Helicobacter Pylori Antibiotic Susceptibility Testing of Korea

NCT02961296 | Unknown

• 1 other identifier: AMC 2016-0467
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Helicobacter Pylori

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  6 more days

Interventions

No intervention OTHER

No intervention will be needed.

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• History of antibiotics more than 3 days sequentially within one month.
• History of subtotal gastrectomy.
• Person who does not agree on the consent.

Sponsors & Collaborators

• Asan Medical Center: lead
• National Evidence-Based Healthcare Collaborating Agency: collaborator

Study Sites (1)

Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center

Seoul, 05505, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Mucosa on the antrum and body of the stomach.

MeSH Terms

Conditions

Peptic Ulcer; Lymphoma; Stomach Neoplasms; Gastritis

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Gastroenteritis

Study Officials

• Hwoon-Yong Jung, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hwoon-Yong Jung, M.D., Ph.D.

CONTACT

hyjung@amc.seoul.kr

Ji Yong Ahn, M.D., Ph.D.

CONTACT

ji110@hanmail.net

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: November 10, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: November 10, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)