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

Eradication of H. Pylori With the Regimen Individualized Susceptibility of H. Pylori to Clarithromycin Determined by the Mutation of 23S rRNA of H. Pylori

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

Study Overview

• Status: Unknown
• Conditions: H. Pylori Infection
• Intervention / Treatment: Drug: Eradication of H. pylori

Detailed Description

Patients infected with H. pylori undergo the gastroscopy. During the gastroscopy, gastric mucus samples are collected, from which DNA is extracted. The DNA samples are subjected the full-auto SNP analyzer and the from A to G mutation of 23s rRNA of H. pylori at the positions of 2142 and 2143 is measured. When the mutation is detected, patients are diagnosed to be infected with clarithromycin-resistant strains of H. pylori and therefore, treated with the triple therapy with vonoprazan 20 mg bid + amoxicillin 750 mg bid + metronidazole 250 mg bid for 1 week. When the mutation is not detected, patients are considered to be infected with clarithromycin-sensitive strains of H. pylori and therefore, treated with the triple therapy with vonoprazan 20 mg bid + amoxicillin 750 mg bid + clarithromycin 200 mg bid for 1 week. The success or failure of eradication was determined based on the 13C-urea breath test performed 1 month after the therapy. The total eradication rates with this strategy was compared with that by the standard regimen in Japan performed in the same period of the study.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: TAKAHISA FURUTA, MD PHD; Phone Number: 81-53-435-2850; Email: tafuruta@fd6.so-net.ne.jp
• Study Contact Backup: Name: Naomi Hashimoto, PhD; Phone Number: 81-53-435-2006; Email: nhashi@hama-med.ac.jp

Study Locations

• Japan
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 23S rRNA wt; 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; 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.; Other Names: Eradication regimen for H. pylori based on SNPs of 23S RNA; Tailored eradication based on genetics
Experimental: 23S rRNA mutation; 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; 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.; Other Names: Eradication regimen for H. pylori based on SNPs of 23S RNA; Tailored eradication based on genetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Eradication rates	Eradication of H. pylori is measured 1 month after the therapy

Collaborators and Investigators

• Sponsor: Hamamatsu University
• Investigators: Principal Investigator: Takahisa Furuta, MD, PhD, Hamamatsu University

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: May 1, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Estimate): May 4, 2016
• Last Update Submitted That Met QC Criteria: May 1, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Eradication therapy; Mutation of 23S rRNA of H. pylori; Personalized therapy
• Other Study ID Numbers: Hp23SrRNA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data obtained with this study are restricted in our hospital.