UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the effects of aging via glycative stress on commensal skin bacteria Staphylococcus epidermidis
Title of the study (Brief title)	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	Yoshikazu Yonei
Organization	Graduate School of Life and Medical Sciences, Doshisha University
Division name	Anti-Aging Medical Research Center
Address	1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL	0774-65-6394
Email	yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person	Kyle Haasbroek
Organization	Graduate School of Life and Medical Sciences, Doshisha University
Division name	Anti-Aging Medical Research Center
Address	1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL	0774-65-6382
Homepage URL
Email	qmq5601@mail4.doshisha.ac.jp

Sponsor
Institute	Graduate School of Life and Medical Sciences,Doshisha University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036202