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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025888
Receipt No. R000029762
Scientific Title Lactobacillus supplement intake test
Date of disclosure of the study information 2017/01/31
Last modified on 2018/06/21

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Basic information
Public title Lactobacillus supplement intake test
Acronym Lactobacillus supplement intake test
Scientific Title Lactobacillus supplement intake test
Scientific Title:Acronym Lactobacillus supplement intake test
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine the influence on the intestinal environment and skin condition by continuously usingLactobacillus supplement for 4 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes defecation frequency
moisture content of the stratum corneum
Key secondary outcomes transepidermal water loss
questionnaire
Diagnostic imaging(VISIA)
Stratum corneum diagnosis
Adverse event(Inquiry consultation)
Physical inspection

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 Beauty foods (once a day for 4 weeks)
Interventions/Control_2 Placebo (once a day for 4 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
59 years-old >=
Gender Male and Female
Key inclusion criteria 1)Those who have received sufficient explanation about the purpose and contents of this exam, have the ability to consent, fully volunteered with voluntary intention, agreed to participate in the document
2)Japanese males and females between 20 and 59 years old who are concerned about skin dryness and skin roughness such as pimples
3)Those who feel constipation with defecation frequency 3 to 5 times per week
4)Those who can participate in the test schedule
5)Those who can fill in their own diary / questionnaire, and those who can use it
Key exclusion criteria 1)Severe hay fever
2)Those who have allergic diseases such as atopic dermatitis and who are receiving medication under the supervision of a doctor
3)Currently, those who have some type of chronic illness and are undergoing drug treatment
4)Person who changes skin condition before and after menstruation
5)Persons who are allergic to dairy products
6)Those who participated in other clinical or monitoring studies within one month prior to the start of testing, those who wish to participate in other clinical trials during this study
7) Those who routinely use medicines and quasi drugs (constipation medicines, intestinal preparations, rough skin remedies, etc.) that may affect the results of this test within one month from the start of the test
8)Persons who are taking health foods, foods for specified health use, which are likely to affect the results of this test within the first month of the test, and those who intend to intake during the test
9)Those who are pregnant, planning to become pregnant during the examination, those who have hope, those who are breastfeeding
10)Those planned to go abroad or domestic travel during the examination period
11)Those who are scheduled to undergo major changes in the living environment such as relocation and relocation during the examination period
12)In addition, those who judged that the examination responsible doctor is inappropriate as a subject including health and living aspects
Target sample size 96

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Maiko Tajima
Organization Beauty & Health Research_Inc
Division name MedicalResearch Department
Zip code
Address Sankyo Nisisinnjuku Buiding 4F 4-2-18 Nisisinnjuku Shinjuku-ku Tokyo, 160-0023 Japan
TEL 03-5354-7388
Email info@b-hr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Nishimaki
Organization Beauty & Health Research_Inc
Division name Sales Depaetment
Zip code
Address Sankyo Nisisinnjuku Buiding 4F 4-2-18 Nisisinnjuku Shinjuku-ku Tokyo, 160-0023 Japan
TEL 03-5354-7388
Homepage URL
Email nishimaki@b-hr.jp

Sponsor
Institute Beauty & Health Research_Inc
Institute
Department

Funding Source
Organization Takanashi Milk Products 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
Address
Tel
Email

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 株式会社ビューティアンドヘルスリサーチ(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.nchpjournals.com/journals/manuscript.php?msid=1117
Number of participants that the trial has enrolled
Results
This study was to investigate the effects of the intake of Lactobacillus rhamnosus GG (LGG) on the defecation and skin condition of healthy adults by a randomized, double-blind, placebo-controlled study. Total 96 healthy adult volunteers with a tendency of constipation and dry skin were given lyophilized cells of LGG (1.4x10^10cfu/g) or placebo for 4 weeks. The defecation frequency at week 4 significantly increased after intake in both LGG group and placebo group (p<0.01). Fecal quantity at week 4 tended to increase after intake in the LGG group (p<0.1). The stratum corneum hydration of the inner forearm was higher in the LGG group than in the placebo group (p<0.01). After week 4 in the LGG group, the transepidermal water loss from the cheek was lower than before intake. A questionnaire on the skin state indicated that skin condition of the LGG group became better than that of placebo group. These results indicate that oral administration of LGG could positively influence the moisture content of skin by increasing the stratum corneum hydration and by inhibiting transepidermal water loss.
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 Completed
Date of protocol fixation
2017 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 28 Day
Last modified on
2018 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029762

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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