NCT03837990

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 14, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

February 11, 2019

Last Update Submit

May 12, 2019

Conditions

Helicobacter Pylori InfectionResistant Infection

Keywords

Whole genome sequencingPolymorphism

Outcome Measures

Primary Outcomes (1)

  • Eradication rate of HP infection

    intent to treat and per protocol analysis

    12 months

Interventions

Helicobacter Pylori eradication therapyDRUG

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.

Also known as: next-generation sequencing of HP strain and host

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

H. pylori-positive healthy patients

You may qualify if:

  • 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

You may not qualify if:

  • History of previous HP eradication treatment
  • History of partial gastrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Boramae Medical Center

Seoul, Seoul, 138-736, South Korea

RECRUITING

Related Publications (3)

  • 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.

    PMID: 20525969BACKGROUND

  • 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.

    PMID: 24914361BACKGROUND

  • 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.

    PMID: 27707777BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Gastric mucosal tissue sample will be used by remnant tissue of CLO test during gastroduodenoscopy. To protect information of participants, we plan to encrypt/anonymize all identifiers of the subjects and store them in a separate database. Whole genome data will be stored in the database of the laboratory of Seoul National University Hospital, and the patient's medical record information (EMR data) will be stored separately.

Study Officials

  • Ju Han Kim, MD

    Division of Biomedical Informatics,Seoul National University College of Medicine

    STUDY DIRECTOR

Central Study Contacts

Jung Ho Bae, MD

CONTACT

82-10-35827713newsanapd@naver.com

Ji Won Kim, MD

CONTACT

82-10-4279-7028kjwjor@snu.ac.kr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 12, 2019

Study Start

May 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

May 14, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)