H. Pylori InfectionPhase 2EHRNCT02761005
Eradication of H. Pylori Therapy Individualized by the Mutation of 23S rRNA of H. Pylori
A Phase 2 study testing Eradication of H. pylori in people with H. Pylori Infection, run by Hamamatsu University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- H. Pylori Infection
- What is being tested?
- Eradication of H. pylori
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- May 2016to May 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients allergic to the any of the drugs used for eradication of H. pylori.
- Patients who do not agree to the study.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, 431-3192
About this study
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
Patients infected with H. pylori are treated with the individualized regimen which is based on the mutation of 23S rRNA of H. pylori.
Read the 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.
- Conditions
- H. Pylori Infection
- Being tested
- Eradication of H. pylori
- Keywords
- Eradication therapy, Mutation of 23S rRNA of H. pylori, Personalized therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eradication of H. pyloriDrug
Also called Eradication regimen for H. pylori based on SNPs of 23S RNA, Tailored eradication based on genetics
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.
| Study group | Role | What they receive |
|---|---|---|
| 23S rRNA wt | Experimental | 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. Receives: Drug: Eradication of H. pylori |
| 23S rRNA mutation | Experimental | 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, Receives: Drug: Eradication of H. pylori |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rates
Measured: Eradication of H. pylori is measured 1 month after the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H. Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamamatsu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takahisa Furuta, Hamamatsu University
- Investigators
- Takahisa Furuta, MD, PhD, Principal investigator, Hamamatsu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761005
- Sponsor's protocol ID
- Hp23SrRNA
- Acronym
- EHR
- Status last verified
- May 2016
- First submitted
- 25 Apr 2016
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The data obtained with this study are restricted in our hospital.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02761005
- Acronym / sponsor ID
- EHR / Hp23SrRNA
- Conditions
- H. Pylori Infection
- Keywords
- Eradication therapy, Mutation of 23S rRNA of H. pylori, Personalized therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hamamatsu UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 23S rRNA wt | Experimental | Drug: Eradication of H. pyloriAs 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. |
| 23S rRNA mutation | Experimental | Drug: Eradication of H. pyloriAs 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, |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients allergic to the any of the drugs used for eradication of H. pylori.
- Patients who do not agree to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eradication of H. pyloriAlso: Eradication regimen for H. pylori based on SNPs of 23S RNA, Tailored eradication based on geneticsFor 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. | Drug | 23S rRNA mutation, 23S rRNA wt |
Primary outcome
Eradication rates
Time frame: Eradication of H. pylori is measured 1 month after the therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Individual participant dataSharing planned: No. The data obtained with this study are restricted in our hospital.
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HELICOBACTER PYLORI INFECTIONS
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HELICOBACTER PYLORI INFECTIONS
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takahisa Furuta, MD, PhD principal investigator
Hamamatsu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eradication of H. pylori in people with H. Pylori Infection, run by Hamamatsu University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TAKAHISA FURUTA, MD PHD (81-53-435-2850, tafuruta@fd6.so-net.ne.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rates (time frame: Eradication of H. pylori is measured 1 month after the therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.