One Sequencing Find All for Helicobacter Pylori Infection

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

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.

Study Overview

• Status: Unknown
• Conditions: Helicobacter Pylori Infection; Resistant Infection
• Intervention / Treatment: Drug: Helicobacter Pylori eradication therapy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Jung Ho Bae, MD; Phone Number: 2112-5570 82-10-35827713; Email: newsanapd@naver.com
• Study Contact Backup: Name: Ji Won Kim, MD; Phone Number: 82-10-4279-7028; Email: kjwjor@snu.ac.kr

Study Locations

• Korea, Republic of
  • 서울특별시
    • Seoul, 서울특별시, Korea, Republic of, 138-736
      • Recruiting
      • Seoul National University Boramae Medical Center
      • Contact: jungho bae, MD; Phone Number: 1035827713; Email: newsanapd@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

H. pylori-positive healthy patients

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Ju Han Kim, MD, Division of Biomedical Informatics,Seoul National University College of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (ACTUAL): February 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Polymorphism; Whole genome sequencing
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections
• Other Study ID Numbers: 20181011/20-2018-80/112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No