UMIN-CTR Clinical Trial

Basic information
Public 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
Acronym	Eradication of H. Pylori Therapy Individualized by the Mutation of 23S rRNA of H. Pylori (EHR)
Scientific 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
Scientific Title:Acronym	Eradication of H. Pylori Therapy Individualized by the Mutation of 23S rRNA of H. Pylori (EHR)
Region	Japan

Condition
Condition	patients infected with H. pylori
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study the clinical efficacy of tailored regimens based on the mutation of H. pylori which is related the resistance to clarithromycin
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Eradication rates of H. pylori is assessed bythe 13C-urea breath test performed at 1 month after the therapy.
Key secondary outcomes	interview on the adverse events during the treatment, such as diarrhea, loose stool, abdominal pain and allergic reactions.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key 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.
Key exclusion criteria	Patients allergic to the any of the drugs used for eradication of H. pylori. Patients who do not agree to the study.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takahisa Furuta
Organization	Hamamatsu University School of Medicine
Division name	Center for Clinical Research
Zip code
Address	1-20-1, Handayama, Higashi-Ku, Hamamatsu
TEL	053-435-2850
Email	furuta@hama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takahisa Furuta
Organization	Hamamatsu University School of Medicine
Division name	Center for Clinical Research
Zip code
Address	1-20-1, Handayama, Higashi-Ku, Hamamatsu
TEL	053-435-2850
Homepage URL
Email	furuta@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	Under progression
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 04 Month 15 Day
Date trial data considered complete	2018 Year 05 Month 31 Day
Date analysis concluded	2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2016 Year 06 Month 16 Day
Last modified on	2018 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026232

Research Plan
Registered date	File name
2016/06/28	☆(4)研究計画書2016.03.24.R2.doc

Research case data specifications
Registered date	File name
2016/06/28	(13)23srRNA症例報告書（CRF）R2.docx

Research case data
Registered date	File name

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