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NCT Number: NCT05247112

Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea

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

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location status: Recruiting

Location contact

Nayoung Kim

CONTACT

[email protected]

82317877009

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

PRINCIPAL_INVESTIGATOR

CONTACT

821052164932

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Resistance rate

    Time frame: through study completion, an average of 1 year

    It means resistance to an antimicrobial agent applicable for H. pylori eradication. Minimal inhibitory concentration test was performed for amoxicillin, clarithromycin, metronidazole, tetracycline, rifabutin, levofloxacin, and moxifloxacin using agar dilution method.

  2. Minimal inhibitory concentration (MIC) distribution

    Time frame: through study completion, an average of 1 year

    The concentration of specific antibiotics that can kill 50% of H. pylori is defined as MIC50. Each analyzes the ratio of strain according to the concentration of antibiotics.

  3. Multiple resistance, prevalance and trends

    Time frame: through study completion, an average of 1 year

    It is defined as the case where the H. pylori strain shows resistance to several antimicrobial agents at the same time. Multiple resistance is calculated by calculating the proportion of strains with simultaneous resistance to 1> clarithromycin and metronidazole, 2> clarithromycin and fluoroquinolone, and 3> clarithromycin, fluoroquinolone, and metronidazole.

Secondary outcomes

  1. Risk factor for eradication failure or success

    Time frame: through study completion, an average of 1 year

    Risk factors for eradication failure or success could be found in the demographic profile of the study subject along with resistance/non-resistance to each antibiotic to H. pylori and its strain.

    According to previous studies, risk factors related with eradication failure or success are usually known from demographic data such as age, sex, and history of eradication treatment. In our study, we use logistic regression analysis to find out whether these factors have significance.

Study contacts

Contact information is provided by the study sponsor or research team.

Jung Won Lee, M.D.

CONTACT

[email protected]

+ 82-10-9356-7758

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

CONTACT

[email protected]

+ 82-31-787-7008

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Important dates

Study start
2003
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2022
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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