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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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H. Pylori Infection

Intervention / Treatment
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* Drug: Eradication of H. pylori


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 23S rRNA wt<br>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<br>* 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.<br>* Other names: Tailored eradication based on genetics;|
| Experimental: 23S rRNA mutation<br>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<br>* 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.<br>* Other names: Tailored eradication based on genetics;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eradication therapy, Mutation of 23S rRNA of H. pylori, Personalized therapy