One Sequencing Find All for Helicobacter Pylori Infection

Study Overview
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Brief Summary
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The aim of this study is to Identify antibiotic resistance gene mutations in Helicobacter pylori (HP) and genetic diversity of drug metabolism for antibiotics and proton pump inhibitors (PPIs) in patients with HP infection using next-generation sequencing (NGS). The mutation of host/HP strain will be investigated by single NGS, and the eradication results according to genetic polymorphism of host/HP strain will be analyzed.

Detailed Description
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This study is a prospective observational study for the Helicobacter pylori (HP) infected patients on typical gastroduodenoscopy (EGD) at Boramae Hospital, Seoul, Korea. 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.

Official Title
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Development of Prediction Model of Treatment Outcome of Helicobacter Pylori Eradication Through One Sequencing Find All Approach: With Whole Exome Sequencing for Host and Target Sequencing for Bacteria at Once

Conditions
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Helicobacter Pylori Infection, Resistant Infection

Intervention / Treatment
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* Drug: Helicobacter Pylori eradication therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years old 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 previous HP eradication treatment History of partial gastrectomy

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication rate of HP infection | intent to treat and per protocol analysis | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Whole genome sequencing, Polymorphism