Helicobacter Pylori InfectionNCT02961296
Helicobacter Pylori Antibiotic Susceptibility Testing of Korea
An observational study of Helicobacter Pylori Infection and Peptic Ulcer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to make nationwide registry for antimicrobial resistance of Helicobacter pylori using single method with agar dilution in Korea. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Helicobacter Pylori Infection, Peptic Ulcer, Lymphoma
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2016to Dec 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects required to the examination of Helicobacter pylori infection is necessary during upper gastrointestinal endoscopy due to peptic ulcer, lymphoma, gastric cancer, gastritis, et al.
Who may be able to join
- Aged 19 to 79 year person who need the examination of Helicobacter pylori infection during upper gastrointestinal endoscopy.
- No history of Helicobacter pylori eradication.
- No history of antibiotics within one month.
- Person who agree on the consent.
Who cannot join
- History of antibiotics more than 3 days sequentially within one month.
- History of subtotal gastrectomy.
- Person who does not agree on the consent.
Trial locations and contacts
1 site in 1 country.
Hwoon-Yong Jung, M.D., Ph.D. contact
Ji Yong Ahn, M.D., Ph.D. contact
South Korea1 site
Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center
Seoul, 05505
Ji Yong Ahn, M.D., Ph.D., ji110@hanmail.net
About this study
The purpose of this study is to make nationwide registry for antimicrobial resistance of Helicobacter pylori using single method with agar dilution in Korea.
Read the detailed description
Backgrounds:
The success rate of Helicobacter pylori eradication in Korea is not sufficient in recent days. The main cause of eradication failure is known as antimicrobial resistance and previous studies showed that resistant rates were different according to the regions in Korea. However, until now, there are not enough studies about the nationwide results for antimicrobial resistance and previous reports used various methods for the resistant test.
Theories and Plans:
The nationwide resistant registry of Helicobacter pylori using standardized single method, agar dilution test, can be useful for the development of new eradication methods to make eradication rate higher. Moreover, the higher rate of Helicobacter pylori eradication can reduce the chance of gastric cancer and also can reduce the medical expenses.
- Conditions
- Helicobacter Pylori Infection, Peptic Ulcer, Lymphoma, Gastric Cancer, Gastritis
- Being tested
- No intervention
- Keywords
- Helicobacter Pylori
- Medical subject headings
- Peptic Ulcer, Lymphoma, Stomach Neoplasms, Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention will be needed.
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of exceeding the resistance criteria in Helicobacter pylori(H. pylori) antibiotic susceptibility test(Agar dilution method)
The resistance criterion specifies that Clarithromycin is excess of 1.0 μg/mL, Amoxicillin is excess of 0.5 μg/mL, Metronidazole is excess of 8 μg/mL, Tetracycline is excess of 4 μg/mL, Levofloxacin is excess of 1 μg/mL and Ciprofloxacin is excess of 1 μg/mL.
All of resistance criteria follow a criteria of NCCLS(National Committee for Clinical Laboratory Standards)
Measured: 6 more days
Secondary outcomes (2)
The gap of the rate of the antibiotic resistance to H. pylori by regional groups
Measured: 6 more days
The success rate of H. pylori strain separation
Analyze the case of inseparable H. pylori strain and the reason of failure for culture after H. pylori strain separation.
Measured: 6 more days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Cross-sectional
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency
- Responsible party
- Principal investigator, Hwoon-Yong Jung, Asan Medical Center
- Investigators
- Hwoon-Yong Jung, Professor, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961296
- Sponsor's protocol ID
- AMC 2016-0467
- Status last verified
- Nov 2016
- First submitted
- 26 Oct 2016
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Antibiotic Susceptibility Testing of Korea
- ClinicalTrials.gov ID
- NCT02961296
- Acronym / sponsor ID
- AMC 2016-0467
- Conditions
- Helicobacter Pylori Infection, Peptic Ulcer, Lymphoma, Gastric Cancer, Gastritis
- Keywords
- Helicobacter Pylori
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- National Evidence-Based Healthcare Collaborating Agency
- Study start
- Oct 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 10 Nov 2016 (estimated)
- 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.
The purpose of this study is to make nationwide registry for antimicrobial resistance of Helicobacter pylori using single method with agar dilution in Korea.
Detailed description
Backgrounds:
The success rate of Helicobacter pylori eradication in Korea is not sufficient in recent days. The main cause of eradication failure is known as antimicrobial resistance and previous studies showed that resistant rates were different according to the regions in Korea. However, until now, there are not enough studies about the nationwide results for antimicrobial resistance and previous reports used various methods for the resistant test.
Theories and Plans:
The nationwide resistant registry of Helicobacter pylori using standardized single method, agar dilution test, can be useful for the development of new eradication methods to make eradication rate higher. Moreover, the higher rate of Helicobacter pylori eradication can reduce the chance of gastric cancer and also can reduce the medical expenses.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects required to the examination of Helicobacter pylori infection is necessary during upper gastrointestinal endoscopy due to peptic ulcer, lymphoma, gastric cancer, gastritis, et al.
Key inclusion criteria (4 listed)
- Aged 19 to 79 year person who need the examination of Helicobacter pylori infection during upper gastrointestinal endoscopy.
- No history of Helicobacter pylori eradication.
- No history of antibiotics within one month.
- Person who agree on the consent.
Key exclusion criteria (3 listed)
- History of antibiotics more than 3 days sequentially within one month.
- History of subtotal gastrectomy.
- Person who does not agree on the consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention will be needed. | Other | – |
Primary outcome
The rate of exceeding the resistance criteria in Helicobacter pylori(H. pylori) antibiotic susceptibility test(Agar dilution method)
Time frame: 6 more days
The resistance criterion specifies that Clarithromycin is excess of 1.0 μg/mL, Amoxicillin is excess of 0.5 μg/mL, Metronidazole is excess of 8 μg/mL, Tetracycline is excess of 4 μg/mL, Levofloxacin is excess of 1 μg/mL and Ciprofloxacin is excess of 1 μg/mL. All of resistance criteria follow a criteria of NCCLS(National Committee for Clinical Laboratory Standards)
2 secondary outcomes
The gap of the rate of the antibiotic resistance to H. pylori by regional groups
Time frame: 6 more days
The success rate of H. pylori strain separation
Time frame: 6 more days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
- 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. This study is not recruiting at the moment.
Hwoon-Yong Jung, M.D., Ph.D. contact
Ji Yong Ahn, M.D., Ph.D. contact
Hwoon-Yong Jung, Professor principal investigator
Asan Medical Center
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 Peptic Ulcer, run by Asan Medical Center 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Nov 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hwoon-Yong Jung, M.D., Ph.D. (hyjung@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of exceeding the resistance criteria in Helicobacter pylori(H. pylori) antibiotic susceptibility test(Agar dilution method) (time frame: 6 more days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2016.