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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032993
Receipt No. R000037626
Scientific Title Relationship between ALDH2/ADH1B phenotypes and ethanol/acetaldehyde levels in the oral cavity of teenagers
Date of disclosure of the study information 2018/06/14
Last modified on 2018/06/14

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Basic information
Public title Relationship between ALDH2/ADH1B phenotypes and ethanol/acetaldehyde levels in the oral cavity of teenagers
Acronym Relationship between ALDH2/ADH1B phenotypes and ethanol/acetaldehyde levels in the oral cavity of teenagers
Scientific Title Relationship between ALDH2/ADH1B phenotypes and ethanol/acetaldehyde levels in the oral cavity of teenagers
Scientific Title:Acronym Relationship between ALDH2/ADH1B phenotypes and ethanol/acetaldehyde levels in the oral cavity of teenagers
Region
Japan

Condition
Condition A healthy teenager
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To elucidate relationship between ALDH2/ADH1B phenotypes and oral alcoholic metabolism in teenagers
Basic objectives2 Others
Basic objectives -Others To elucidate microbiome related to oral alcoholic metabolism in teenager
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Breath ethanol and acetaldehyde levels
Key secondary outcomes ADH1B and ALDH2 genotypes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 A subject is instructed to refrain from eating foods and drinking except water for 1 hour prior to the study. In this study, at first, a subject is sampled the endogenous breath using a gas bag, and then is sampled the breath a gas bag after keeping 200ul of 0.1% alcohol for 10 seconds in the oral cavity.
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
16 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria -High school student at the age of 16-18.
-Male and Female
-A person who is provided sufficient explanations about this study and consented to it in writing by his/her own free will
-A person who has no history of drinking and smoking
Key exclusion criteria -an inappropriate person for this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Fujimiya
Organization Graduate School of Medicine, Yamaguchi University
Division name Department of Legal Medicine
Zip code
Address Minami-kogushi 1-1-1, Ube, Yamaguchi 755-8505 JAPAN
TEL 0836-22-2234
Email fujimiya@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayako Himemiya-Hakucho
Organization Graduate School of Medicine, Yamaguchi University
Division name Department of Legal Medicine
Zip code
Address Minami-kogushi 1-1-1, Ube, Yamaguchi 755-8505 JAPAN
TEL 0836-22-2234
Homepage URL
Email haku.a@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Institute
Department

Funding Source
Organization None
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
2018 Year 06 Month 14 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
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
2018 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 06 Month 14 Day
Last modified on
2018 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037626

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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