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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02761005
Acronym
EHR
Enrollment
100
Registered
2016-05-04
Start date
2016-05-31
Completion date
2018-05-31
Last updated
2016-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H. Pylori Infection

Keywords

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

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.

Interventions

DRUGEradication 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.

Sponsors

Hamamatsu University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

Japan

Contacts

Primary ContactTAKAHISA FURUTA, MD PHD
tafuruta@fd6.so-net.ne.jp81-53-435-2850
Backup ContactNaomi Hashimoto, PhD
nhashi@hama-med.ac.jp81-53-435-2006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026