UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031696 |
|---|---|
| Receipt number | R000036202 |
| Scientific Title | Study of the effects of aging via glycative stress on commensal skin bacteria Staphylococcus epidermidis |
| Date of disclosure of the study information | 2018/03/15 |
| Last modified on | 2018/09/13 16:30:14 |
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Basic information
Public title
Study of the effects of aging via glycative stress on commensal skin bacteria Staphylococcus epidermidis
Acronym
Impact of aging and glycative stress on skin bacterial flora
Scientific Title
Study of the effects of aging via glycative stress on commensal skin bacteria Staphylococcus epidermidis
Scientific Title:Acronym
Impact of aging and glycative stress on skin bacterial flora
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the relationship between advanced glycation endproduct accumulation in the skin associated with aging, and the health of the human skin microbiome, utilizing Staphylococcus epidermidis as an indicator species
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Data on the amount of fluorescent advanced glycation endproducts accumulated in the epidermis, N(6)-Carboxymethyllysine in the stratum corneum, and Staphylococcus epidermidis on the surface of the skin
Key secondary outcomes
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]Individuals between the ages of 20-29, who belong to the Faculty of Life and Medical Sciences / Graduate School of Life and Medical Sciences at Doshisha university
[2]Individuals aged 65<= who have previously undergone anti-aging medical checkups
Key exclusion criteria
[1]Those who have used antibiotics within 30 days of testing
[2]Those suffering from an acute or chronic infection
[3]Those suffering from a chronic medical condition for which they are undergoing medical treatment
[4]Those with a significant injury and/or disease of the skin
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Yonei |
Organization
Graduate School of Life and Medical Sciences, Doshisha University
Division name
Anti-Aging Medical Research Center
Zip code
Address
1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL
0774-65-6394
yyonei@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyle Haasbroek |
Organization
Graduate School of Life and Medical Sciences, Doshisha University
Division name
Anti-Aging Medical Research Center
Zip code
Address
1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL
0774-65-6382
Homepage URL
qmq5601@mail4.doshisha.ac.jp
Sponsor or person
Institute
Graduate School of Life and Medical Sciences,Doshisha University
Institute
Department
Personal name
Funding Source
Organization
Doshisha University
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
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 | 03 | Month | 15 | 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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Perform the following inspections once a month, four times in total.
Data on the amount of fluorescent advanced glycation endproducts accumulated in the epidermis, N(6)-Carboxymethyllysine in the stratum corneum, and Staphylococcus epidermidis on the surface of the skin
Management information
Registered date
| 2018 | Year | 03 | Month | 13 | Day |
Last modified on
| 2018 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036202
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
