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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000038300
Receipt No. R000043434
Scientific Title Evaluation of effects of consumption of lactic acid bacteria on skin conditions of females
Date of disclosure of the study information 2019/10/15
Last modified on 2020/06/30

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Basic information
Public title Evaluation of effects of consumption of lactic acid bacteria on skin conditions of females
Acronym Evaluation of effects of consumption of lactic acid bacteria on skin conditions of females
Scientific Title Evaluation of effects of consumption of lactic acid bacteria on skin conditions of females
Scientific Title:Acronym Evaluation of effects of consumption of lactic acid bacteria on skin conditions of females
Region
Japan

Condition
Condition No
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of lactic acid bacteria on skin condition in healthy females.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin hydration in stratum corneum and transepidermal water loss
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 Prevention
Type of intervention
Food
Interventions/Control_1 A beverage containing lactic acid bacteria (130 mL/day for 8 weeks)
Interventions/Control_2 A beverage not containing lactic acid bacteria (130 mL/day for 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
20 years-old <=
Age-upper limit
60 years-old >
Gender Female
Key inclusion criteria 1. Japanese healthy females aged 20 to 59 years-old at acquisition of the consent.
2. Who have subjective symptoms of dry skin
3. Who can make self-judgment, voluntarily agreed to participate to this study, and provide written informed consent.
Key exclusion criteria 1. Who have any disease
2. Who take any medicines or foods which affect intestinal flora
3. Who take any medicines or foods which affect skin moisture
4. Who have allergic to apple, soy bean, dairy food
5. Who had surgery or treatment on skin within two months
6. Who expose to high-intensity ultraviolet rays.
7. Who are pregnant or breast-feeding or willing to be pregnant during this study.
8. Who have participated in other clinical study for skin during this study, or willing to be that.
9. A person of irregular habits.
10, Who are judged unsuitable for this study by principal investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Shigenori
Middle name
Last name Suzuki
Organization KAGOME CO., LTD.
Division name Nature & Wellness Research Department
Zip code 329-2762
Address 17 Nishitomiyama, Nasushiobara city, Tochigi
TEL 0287-36-2935
Email Shigenori_Suzuki@kagome.co.jp

Public contact
Name of contact person
1st name Naoko
Middle name
Last name Waki
Organization KAGOME CO., LTD.
Division name Nature & Wellness Research Department
Zip code 329-2762
Address 17 Nishitomiyama, Nasushiobara city, Tochigi
TEL 0287-36-2935
Homepage URL
Email Naoko_Waki@kagome.co.jp

Sponsor
Institute KAGOME CO., LTD.
Institute
Department

Funding Source
Organization KAGOME CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Kirei Testing Labo Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kagome Ethics Committee
Address 3-21-1, F tower, Hamacho, Nihonbashi, Tyuo-ku, Tokyo, Japan
Tel 03-5623-8501
Email Takuji_Hayakawa@kagome.co.jp

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 株式会社きれいテストラボ(東京都)/Kirei Testing Labo Co., Ltd. (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 99
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 Main results already published
Date of protocol fixation
2019 Year 08 Month 27 Day
Date of IRB
2019 Year 08 Month 27 Day
Anticipated trial start date
2019 Year 10 Month 16 Day
Last follow-up date
2019 Year 12 Month 19 Day
Date of closure to data entry
2020 Year 01 Month 31 Day
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 10 Month 15 Day
Last modified on
2020 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043434

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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