UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Lactobacillus supplement intake test
Title of the study (Brief title)	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	Maiko Tajima
Organization	Beauty & Health Research_Inc
Division name	MedicalResearch Department
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	Yuji Nishimaki
Organization	Beauty & Health Research_Inc
Division name	Sales Depaetment
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.nchpjournals.com/journals/manuscript.php?msid=1117
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.
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