One Sequencing Find All for Helicobacter Pylori Infection

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03837990
• Other study ID #: 20181011/20-2018-80/112
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2019
• Source: Seoul National University Hospital
• Contact: Jung Ho Bae, MD
• Phone: 82-10-35827713
• Email: newsanapd[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection
• Resistant Infection

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul	?????

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate of HP infection	intent to treat and per protocol analysis	12 months