UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035719
Receipt number 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 14:32:45

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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 or person

Institute

Shiba Palace Clinic

Institute

Department

Personal name



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

Value
https://center6.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