Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea

NCT ID: NCT05247112

Last Updated: 2023-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-07-01

Study Completion Date

2027-12-31

Brief Summary

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To assess antimicrobial resistance rates and minimal inhibitory concentrations in H. pylori isolated from patients with upper gastrointestinal disease with long-term period.

Detailed Description

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Failure of eradication treatment against Helicobacter pylori (H. pylori) is mainly caused by antimicrobial resistance. However, there is no relevant studies have been conducted on the prevalence and trend of antimicrobial resistance, which is considered to have a major determinant of eradication failure. In addition, studying the trend of resistance rate is an important basis for establishing an appropriate strategy for eradication treatment in the future.

Patients who had H. pylori colonies isolated from culture were consecutively enrolled from 2003. From each patient, 1 to 10 H. pylori isolates were isolated. Trends in MIC distribution and prevalence of resistance were investigated for each antimicrobial agent according to time period. Antimicrobi resistances suspected to related with failure of empirical PPI triple, quadruple, and rescue fluoroquinolone-containing treatment were also investigated. Multiple resistance, which is simultaneously resistant to various antibiotics, will also be investigated. Risk factors for the antibiotic resistance will be analyzed.

Conditions

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Helicobacter Pylori Infection Helicobacter Pylori Associated Gastrointestinal Disease Helicobacter Pylori Infection, Susceptibility to Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Subjects who had a H. pylori infection and had consented to undergo culture analysis via endoscopic resection, in order to determine the minimal inhibitory concentration (MIC) of various antibiotics.

Exclusion Criteria

* Patients with a concurrent critical illness, who abused drugs or alcohol, who were pregnant or nursing, or those who had received antibiotics, PPIs, or bismuth salts within 4 weeks, were excluded.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nayoung Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nayoung Kim, M.D., Ph.D

Role: STUDY_CHAIR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jung Won Lee, M.D.

Role: CONTACT

+ 82-10-9356-7758

Nayoung Kim, M.D., Ph.D.

Role: CONTACT

+ 82-31-787-7008

Facility Contacts

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Nayoung Kim

Role: primary

82317877009

Role: backup

821052164932

References

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Lee JW, Kim N, Choi SI, Jang JY, Song CH, Nam RH, Lee DH. Prevalence and trends of multiple antimicrobial resistance of Helicobacter pylori in one tertiary hospital for 20 years in Korea. Helicobacter. 2023 Feb;28(1):e12939. doi: 10.1111/hel.12939. Epub 2022 Dec 7.

Reference Type DERIVED
PMID: 36478622 (View on PubMed)

Other Identifiers

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B-1504-294-305

Identifier Type: -

Identifier Source: org_study_id

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