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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Resistance rate | 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. | through study completion, an average of 1 year |
| Minimal inhibitory concentration (MIC) distribution | 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. | through study completion, an average of 1 year |
| Multiple resistance, prevalance and trends | 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. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Risk factor for eradication failure or success | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The subjects of this study all had H. pylori infection. None of them should meet the exclusion criteria. Even though successfully proven H. pylori infection, culture procedures must be successful and the susceptibility must be clearly determined by obtaining MIC values to be finally included in this study. According to the literature, culture is successful at approximately 2/3. Informed consent will be obtained from all study subjects.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung Won Lee, M.D. | Contact | + 82-10-9356-7758 | saludos@naver.com | |
| Nayoung Kim, M.D., Ph.D. | Contact | + 82-31-787-7008 | nakim49@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Nayoung Kim, M.D., Ph.D | Seoul National University Bundang Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36478622 | Derived | 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. |
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H. pylori strains isolated by study subjects.
Susceptibility is investigated for each of the H. pylori strains, and mutations (e.g., 23SrRNA, gyrA, etc.) that can decisively cause resistance can be investigated only if necessary. All consent to these biosamples will be obtained in advance.
| through study completion, an average of 1 year |