Helicobacter Pylori InfectionNCT05247112
Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea
An observational study of Helicobacter Pylori Infection and Helicobacter Pylori Associated Gastrointestinal Disease, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
To assess antimicrobial resistance rates and minimal inhibitory concentrations in H. pylori isolated from patients with upper gastrointestinal disease with long-term period. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Helicobacter Pylori Infection, Helicobacter Pylori Associated Gastrointestinal Disease, Helicobacter Pylori Infection, Susceptibility to
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2003to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Nayoung Kim, 82317877009, nayoungkim49@empas.com
821052164932
About this study
To assess antimicrobial resistance rates and minimal inhibitory concentrations in H. pylori isolated from patients with upper gastrointestinal disease with long-term period.
Read the 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.
- Conditions
- Helicobacter Pylori Infection, Helicobacter Pylori Associated Gastrointestinal Disease, Helicobacter Pylori Infection, Susceptibility to, Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation
- Keywords
- eradication, rescue therapy, antibiotics, resistance, Helicobacter pylori
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Jul 2003
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
- Investigators
- Nayoung Kim, M.D., Ph.D, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247112
- Sponsor's protocol ID
- B-1504-294-305
- Status last verified
- Apr 2023
- First submitted
- 18 Jan 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi Y, Kim N, Lee JY, Lee JW, Lee HD, Lee J, Jo SY, Nam RH, Shin CM. Sex Differences in Helicobacter pylori Antimicrobial Resistance among 890 Subjects over 20 Years in a Korean Tertiary Hospital. Gut Liver. 2026 Sep 15. doi: 10.5009/gnl260357. Online ahead of print.
PubMed 42744342Lee 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.
PubMed 36478622
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea
- ClinicalTrials.gov ID
- NCT05247112
- Acronym / sponsor ID
- B-1504-294-305
- Conditions
- Helicobacter Pylori Infection, Helicobacter Pylori Associated Gastrointestinal Disease, Helicobacter Pylori Infection, Susceptibility to, Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation
- Keywords
- eradication, rescue therapy, antibiotics, resistance, Helicobacter pylori
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Jul 2003 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
1 secondary outcome
Risk factor for eradication failure or success
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Derived from this study: PubMed 42744342Choi Y, Kim N, Lee JY, Lee JW, Lee HD, Lee J, Jo SY, Nam RH, Shin CM. Sex Differences in Helicobacter pylori Antimicrobial Resistance among 890 Subjects over 20 Years in a Korean Tertiary Hospital. Gut Liver. 2026 Sep 15. doi: 10.5009/gnl260357. Online ahead of print.
- Derived from this study: PubMed 36478622Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nayoung Kim, M.D., Ph.D study chair
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection and Helicobacter Pylori Associated Gastrointestinal Disease, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jung Won Lee, M.D. (+ 82-10-9356-7758, saludos@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resistance rate (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05247112, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.