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

Phase 2

• Conditions: H. Pylori Infection
• Interventions: Drug: Eradication of H. pylori

• Registration Number: NCT02761005
• Lead Sponsor: Hamamatsu University

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.

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 Timeline

• Study First Submitted: 2016-04-25
• Status Verified: 2016-05
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-01
• Last Update Submitted: 2016-05-01
• Study First Posted: 2016-05-04
• Last Update Posted: 2016-05-04
• Primary Completion: 2018-03
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
23S rRNA mutation	Eradication of H. pylori	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,
23S rRNA wt	Eradication of H. pylori	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.

Primary Outcome Measures

Name	Time	Method
Eradication rates	Eradication of H. pylori is measured 1 month after the therapy

Trial Locations

Locations (1)

Hamamatsu University School of Medicine; 🇯🇵 Hamamatsu, Shizuoka, Japan