UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of tailored Helicobacter pylori eradication therapy based on susceptibility to antimicrobial agents
Title of the study (Brief title)	Efficacy of tailored HP eradication based on susceptibility to antimicrobial agents
Region	Japan

Condition
Condition	H. pylori-associated gastritis
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify efficacy of tailored eradication therapy based on susceptibility to antimicrobial agents.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Eradication rate of tailored eradication therapy based on susceptibility to antimicrobial agents.
Key secondary outcomes	1. Eradication rate of tailored tailored H. pylori eradication therapy based on susceptibility to antimicrobial agents among different CYP2C19, CYP3A4, CYP3A5 genotypes. 2.Change of abdominal symptoms between before and after eradication therapy

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Conventional:7 days VPZ20mg/AMPC750mg/CAM200mg bid
Interventions/Control_2	Tailored: 7 days 1. CAM-S: VPZ20mg/AMPC750mg/CAM200mg bid 2. CAM-R: VPZ20mg/AMPC750mg/MNZ250mg bid
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Age; mere than 20 years 2. With informed consent 3. Positive for culture test of H. pylori
Key exclusion criteria	1. With malignant diseases 2. Negative for culture test 3. With severe liver disease 4. No informed consent 5. Not suitable by judgement of Medical Doctor
Target sample size	310

Research contact person
Name of lead principal investigator	Mitsushige Sugimoto
Organization	Shiga University of Medical Science Hospital
Division name	Division of Digestive Endoscopy
Address	Seta Tsukinowa-cho, Otsu, Shiga
TEL	077-548-2618
Email	sugimo@belle.shiga-med.ac.jp

Public contact
Name of contact person	Mitsushige Sugimoto
Organization	Shiga University of Medical Science Hospital
Division name	Division of Digestive Endoscopy
Address	Seta Tsukinowa-cho, Otsu, Shiga
TEL	077-548-2618
Homepage URL
Email	sugimo@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science Hospital
Institute
Department

Funding Source
Organization	Shiga University of Medical Science Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2017 Year 12 Month 05 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 05 Month 19 Day
Anticipated trial start date	2016 Year 05 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 05 Day
Last modified on	2017 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026664