Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-25 @ 5:44 PM
Study NCT ID:
NCT02761005
Status:
UNKNOWN
Last Update Posted:
2016-05-04
First Post:
2016-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eradication of H. Pylori Therapy Individualized by the Mutation of 23S rRNA of H. Pylori
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-01', 'studyFirstSubmitDate': '2016-04-25', 'studyFirstSubmitQcDate': '2016-05-01', 'lastUpdatePostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication rates', 'timeFrame': 'Eradication of H. pylori is measured 1 month after the therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Eradication therapy', 'Mutation of 23S rRNA of H. pylori', 'Personalized therapy'], 'conditions': ['H. Pylori Infection']}, 'descriptionModule': {'briefSummary': 'Patients infected with H. pylori are treated with the individualized regimen which is based on the mutation of 23S rRNA of H. pylori.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients infected with H. pylori are invited to the study.\n* Patients not allergic to the any of the drugs used for eradication of H. pylori.\n* Patients who has agreed to participate to the study.\n\nExclusion Criteria:\n\n* Patients allergic to the any of the drugs used for eradication of H. pylori.\n* Patients who do not agree to the study.'}, 'identificationModule': {'nctId': 'NCT02761005', 'acronym': 'EHR', 'briefTitle': 'Eradication of H. Pylori Therapy Individualized by the Mutation of 23S rRNA of H. Pylori', 'organization': {'class': 'OTHER', 'fullName': 'Hamamatsu University'}, 'officialTitle': 'Eradication of H. Pylori With the Regimen Individualized Susceptibility of H. Pylori to Clarithromycin Determined by the Mutation of 23S rRNA of H. Pylori', 'orgStudyIdInfo': {'id': 'Hp23SrRNA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '23S rRNA wt', '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.', 'interventionNames': ['Drug: Eradication of H. pylori']}, {'type': 'EXPERIMENTAL', 'label': '23S rRNA mutation', '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,', 'interventionNames': ['Drug: Eradication of H. pylori']}], 'interventions': [{'name': 'Eradication of H. pylori', 'type': 'DRUG', 'otherNames': ['Eradication regimen for H. pylori based on SNPs of 23S RNA', 'Tailored eradication based on genetics'], 'description': '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.', 'armGroupLabels': ['23S rRNA mutation', '23S rRNA wt']}]}, 'contactsLocationsModule': {'locations': [{'zip': '431-3192', 'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Hamamatsu University School of Medicine', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}], 'centralContacts': [{'name': 'TAKAHISA FURUTA, MD PHD', 'role': 'CONTACT', 'email': 'tafuruta@fd6.so-net.ne.jp', 'phone': '81-53-435-2850'}, {'name': 'Naomi Hashimoto, PhD', 'role': 'CONTACT', 'email': 'nhashi@hama-med.ac.jp', 'phone': '81-53-435-2006'}], 'overallOfficials': [{'name': 'Takahisa Furuta, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamamatsu University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data obtained with this study are restricted in our hospital.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamamatsu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Takahisa Furuta', 'investigatorAffiliation': 'Hamamatsu University'}}}}