UMIN-CTR Clinical Trial

Basic information
Public title	Influenced factor for outcome of H. pylori eradication therapy: retrospective study
Acronym	Association with H. pylori eradication and CYP3A4/5 type
Scientific Title	Influenced factor for outcome of H. pylori eradication therapy: retrospective study
Scientific Title:Acronym	Association with H. pylori eradication and CYP3A4/5 type
Region	Japan

Condition
Condition	H. pylori infection associated gastritis
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To clarify influenced factor of outcome of H. pylori eradication therapy using PPI or vonprazan (alcohol, smoking, CYP2C19 genotype, CYP3A4/5 genotype, compliance and susceptibility to antimicrobial agents)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Eradication rate of H. pylori infection
Key secondary outcomes	(1) incidence rate of adverse effects (2) influence of CYP2C19 genotypes for outcome of eradication therapy (3) influence of CYP3A4/5 genotypes for outcome of eradication therapy (4) influence of susceptibility to antimicrobial agents for outcome of eradication therapy

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. patients eradicated H. pylori form April 2013 to July 2016 in Shiga University of Medical Science Hospital. 2. patients received informed consent previously for genotyping of CYP2C19 and drug-metabolized enzyme genes.
Key exclusion criteria	1. Without informed consent 2. without detail clinical data, such as kinds of eradication regimen, age, sex, side effects, outcome of eradication therapy, severity of gastric mucosal atrophy, status of GERD, peptic ulcer and gastric cancer, smoking, alcohol, and CYP2C19 genotype status.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mitsushige Sugimoto
Organization	Shiga University of Medical Science Hospital
Division name	Division of Digestive Endoscopy
Zip code
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN, 520-2192
TEL	077-548-2618
Email	sugimo@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Mitsushige Sugimoto
Organization	Shiga University of Medical Science Hospital
Division name	Division of Digestive Endoscopy
Zip code
Address	Seta Tsukinowa-cho, Otsu, Shiga, JAPAN, 520-2192
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)

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 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	Completed
Date of protocol fixation	2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2017 Year 01 Month 30 Day
Date analysis concluded	2017 Year 01 Month 30 Day

Other
Other related information	None

Management information
Registered date	2016 Year 09 Month 26 Day
Last modified on	2017 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027827

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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