UMIN-CTR Clinical Trial

Basic information
Public title	Verification of the effect of skin function improvement by intake of lactic acid bacteria.
Acronym	Verification of the effect of skin function improvement.
Scientific Title	Verification of the effect of skin function improvement by intake of lactic acid bacteria.
Scientific Title:Acronym	Verification of the effect of skin function improvement.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of the effect of skin function improvement by intake of lactic acid bacteria.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in skin function before ingestion and after ingestion period
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Test food: ingestion of food containing lactic acid bacteria 1 cupsule/day, 8 weeks
Interventions/Control_2	Pracebo food: ingestion of food not containing lactic acid bacteria 1 cupsule/day, 8 weeks
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	35 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Japanese men and women aged 35 to 59 years old at the time of acquiring consent 2) Persons who care about dry skin 3) Persons who feel sagging skin 4) Persons who are aware of rough skin 5) Persons who are aware of rough skin due to drying, etc. on either the right cheek, the right neck, the upper back, the right shank, the right foot back, or the left cheek, or who have itching symptoms (it is desirable when there is desquamation), or who have flaky skin after bathing, every year from October to March 6) Persons who can stop drinking alcohols from the day before the observation date until the end of the measurement on the observation day 7) Persons who received a sufficient explanation of the purpose of this exam, have the capacity to consent, volunteer for participation after understanding well, and who agreed in writing to participate in this study 8) Persons with stains on their right cheek
Key exclusion criteria	1) Persons who are judged inappropriate by the examining supervisor or doctor in charge of examination 2) Persons with chronic skin symptoms such as atopic dermatitis 3) Persons who used cosmetics containing hyaluronic acid, collagen, ceramide, vitamins etc. within 1 month before start of use 4) Persons who ingested supplements containing hyaluronic acid, collagen, ceramide, vitamins etc. within 1 month before start of use 5) Persons taking or planning to take medicine with hay fever 6) Persons who currently go to dermatology department 7) Persons participating in a test taking other foods or medicines, or applying cosmetics and medicines etc, or participated in similar exams in less than 3 months 8) Persons participating in other clinical trials 9) During pregnancy or planned, or those who are breastfeeding 10) Persons who may have an allergy such as having a history of hypersensitivity to the test article 11) Persons who are likely to have allergic symptoms depending on the test article components 12) Persons with significant abnormalities in the skin condition of the test site (cheek, upper back, neck, elbow, paw) 13) Persons who have chronic illness and regularly use medication 14) Persons who have athema 15) Persons with soy allergy
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Koikeda
Organization	Shiba Palace Clinic
Division name	Chair
Zip code	1050013
Address	6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL	03-5408-1590
Email	jimukyoku@mail.souken-r.com

Public contact
Name of contact person	1st name Ko Middle name Last name MASUDA
Organization	SOUKEN Co., Ltd
Division name	Management Division
Zip code	1050013
Address	3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL	03-5408-1555
Homepage URL
Email	k_masuda@mail.souken-r.com

Sponsor
Institute	Shiba Palace Clinic
Institute
Department

Funding Source
Organization	NISSIN FOODS HOLDINGS CO.,LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shiba Palace Clinic Ethics Review Committee
Address	6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel	03-5408-1590
Email	jimukyoku@mail.souken-r.com

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	2020 Year 01 Month 30 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 11 Month 15 Day
Date of IRB
Anticipated trial start date	2019 Year 01 Month 30 Day
Last follow-up date	2019 Year 11 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 30 Day
Last modified on	2020 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040307