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

H. Pylori Infection Clinical Trial

— EHR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02761005
• Other study ID #: Hp23SrRNA
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 25, 2016
• Last updated: May 1, 2016
• Start date: May 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2016
• Source: Hamamatsu University
• Contact: TAKAHISA FURUTA, MD PHD
• Phone: 81-53-435-2850
• Email: tafuruta[@]fd6.so-net.ne.jp
• Is FDA regulated: No
• Health authority: Japan: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• H. Pylori Infection
• Helicobacter Infections

Intervention

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.

Locations

Country	Name	City	State
Japan	Hamamatsu University School of Medicine	Hamamatsu	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
Hamamatsu University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rates		Eradication of H. pylori is measured 1 month after the therapy	No