Eradication of H. Pylori Therapy Individualized by the Mutation of 23S rRNA of H. Pylori

NCT02761005 | Unknown Phase 2

• 1 other identifier: Hp23SrRNA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients infected with H. pylori are treated with the individualized regimen which is based on the mutation of 23S rRNA of H. pylori.

Conditions

H. Pylori Infection

Keywords

Eradication therapy; Mutation of 23S rRNA of H. pylori; Personalized therapy

Outcome Measures

Primary Outcomes (1)

• Eradication rates

  Eradication of H. pylori is measured 1 month after the therapy

Study Arms (2)

23S rRNA wt

EXPERIMENTAL

As the 23S rRNA mutation guided selection of antimicrobial agent, patients infected with strains without mutation of 23S rRNA are assigned to this arm. In this arm, they are treated with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg bid for 1 week for the eradication of H. pylori.

Drug: Eradication of H. pylori

23S rRNA mutation

EXPERIMENTAL

As the 23S rRNA mutation guided selection of antimicrobial agent, patients infected with strains with mutation of 23S rRNA are assigned to this arm. In this arm, they are treated with vonoprazan 20 mg bid, amoxicillin 750 mg bid and metronidazole 250 mg bid for 1 week for the eradication of H. pylori,

Drug: Eradication of H. pylori

Interventions

Eradication of H. pylori DRUG

For the eradication of H. pylori, patients diagnosed to be infected with strain with mutation of 23S rRNA, their H. pylori strains are considered to be resistant to clarithromycin. Then, they are treated with vonoprazan 40 mg, metronidazole 500 mg and amoxicillin 1500 mg for 1 week. Patients diagnosed to be infected with strain without mutation of 23S rRNA, their H. pylori strains are considered to be resistant to clarithromycin. Then, they are treated with vonoprazan 40 mg, clarithromycin 400 mg and amoxicillin 1500 mg for 1 week.

Also known as: Eradication regimen for H. pylori based on SNPs of 23S RNA, Tailored eradication based on genetics

23S rRNA mutation; 23S rRNA wt

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients infected with H. pylori are invited to the study.
• Patients not allergic to the any of the drugs used for eradication of H. pylori.
• Patients who has agreed to participate to the study.

You may not qualify if:

• Patients allergic to the any of the drugs used for eradication of H. pylori.
• Patients who do not agree to the study.

Sponsors & Collaborators

• Hamamatsu University: lead

Study Sites (1)

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Study Officials

• Takahisa Furuta, MD, PhD

  Hamamatsu University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TAKAHISA FURUTA, MD PHD

CONTACT

81-53-435-2850; tafuruta@fd6.so-net.ne.jp

Naomi Hashimoto, PhD

CONTACT

81-53-435-2006; nhashi@hama-med.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 4, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 4, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)