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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035719
Receipt No. R000040307
Scientific Title Verification of the effect of skin function improvement by intake of lactic acid bacteria.
Date of disclosure of the study information 2020/01/30
Last modified on 2020/01/31

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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/ctr_e/ctr_view.cgi?recptno=R000040307

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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