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

Hamamatsu University

Status and phase: Unknown; Phase 2

Conditions: H. Pylori Infection

Treatments: Drug: Eradication of H. pylori

Study type: Interventional

Funder types: Other

Identifiers

NCT02761005

Hp23SrRNA

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

23S rRNA wt

Experimental group

Description:

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.

Treatment:

Drug: Eradication of H. pylori

23S rRNA mutation

Experimental group

Description:

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,

Treatment:

Drug: Eradication of H. pylori