One Sequencing Find All for Helicobacter Pylori Infection
NCT ID: NCT03837990
Last Updated: 2019-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2019-05-01
2019-12-31
Brief Summary
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Detailed Description
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The presence of antibiotic resistance genes of HP and the diversity of the pharmacokinetic genotypes of the subjects will be investigated by performing single next-generation sequencing (NGS) analysis using gastric mucosal tissue samples of the HP infected subjects.
The purpose of this study is to collect data on the antimicrobial resistance mutation of HP (23S rRNA gene, pbp1 gene, rdxA, frxA, frxB gene, 16S rRNA, gyrA, gyrB gene, and Cag A gene) and to investigate the genetic diversity on the metabolism of antibiotics and proton pump inhibitors (CYP enzyme) in a Korean population.
The investigators are going to compare the results of standard eradication therapy according to the resistance mutation of HP and drug genetic diversity of subjects.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Helicobacter Pylori eradication therapy
Eradication therapy includes the administration of a proton pump inhibitor (PPI) and antibiotics. Triple therapy with a PPI (lansoprazole or esomeprazole), clarithromycin, and amoxicillin is the first-line regimen. Quadruple therapy with a PPI, bismuth, metronidazole, and tetracyclin is the second-line therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CLO test positive
* Findings of gastric ulcer, atrophic gastritis on gastroduodenoscopy
* Agreed to HP eradication therapy and accept to follow-up
* Agreed to participating in the study
Exclusion Criteria
* History of partial gastrectomy
19 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ju Han Kim, MD
Role: STUDY_DIRECTOR
Division of Biomedical Informatics,Seoul National University College of Medicine
Locations
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Seoul National University Boramae Medical Center
Seoul, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010 Aug;59(8):1143-53. doi: 10.1136/gut.2009.192757. Epub 2010 Jun 4.
Sugimoto M, Furuta T. Efficacy of tailored Helicobacter pylori eradication therapy based on antibiotic susceptibility and CYP2C19 genotype. World J Gastroenterol. 2014 Jun 7;20(21):6400-11. doi: 10.3748/wjg.v20.i21.6400.
Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.
Other Identifiers
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20181011/20-2018-80/112
Identifier Type: -
Identifier Source: org_study_id
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