Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Helicobacter Pylori Infection, Helicobacter Pylori Associated Gastrointestinal Disease, Helicobacter Pylori Infection, Susceptibility to, Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Primary outcome measures
- Resistance rate [Time frame: through study completion, an average of 1 year]
- Minimal inhibitory concentration (MIC) distribution [Time frame: through study completion, an average of 1 year]
- Multiple resistance, prevalance and trends [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (1)
- Risk factor for eradication failure or success [Time frame: through study completion, an average of 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
South Korea · 1 center
- Seoul National University Bundang Hospital — Seongnam-si
Publications
- 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. PMID 36478622
Identifiers
NCT: NCT05247112 · B-1504-294-305