UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032993 |
|---|---|
| Receipt number | 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 | 2025/12/19 11:33:13 |
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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 | Ayako |
| Middle name | |
| Last name | Himemiya-Hakucho |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Legal Medicine
Zip code
7558505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi 755-8505 JAPAN
TEL
0836-22-2234
fujimiya@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Himemiya-Hakucho |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Legal Medicine
Zip code
7558505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi 755-8505 JAPAN
TEL
0836-22-2234
Homepage URL
haku.a@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
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
Center For Clinical Research, Yamaguchi University Hospital
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi 755-8505 JAPAN
Tel
0836-22-2428
me223@yamaguchi-u.ac.jp
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
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
106
Results
For the ALDH2 genotype, AcH concentrations were significantly higher in deficiency carriers than in non-carriers. Analysis of the oral bacterial flora revealed that the proportion of Neisseria was significantly higher in ALDH2 deficiency carriers than in non-carriers. Furthermore, positive or negative correlations between AcH concentration and the proportion of multiple bacterial genera and species were identified.
Results date posted
| 2025 | Year | 12 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A healthy teenager
-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
Participant flow
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 saliva and, endogenous breath using a gas bag. Then, sampled the breath a gas bag after keeping 200ul of 0.1% alcohol for 10 seconds in the oral cavity.
Adverse events
None.
Outcome measures
Primary outcomes are breath ethanol and acetaldehyde levels, and key secondary outcomes are ADH1B and ALDH2 genotypes.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 14 | Day |
Last modified on
| 2025 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037626
