UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the effects of Lactobacillus brevis SBC8803 intake on skin in adults
Title of the study (Brief title)	A study on the effects of Lactobacillus brevis SBC8803 intake on skin
Region	Japan

Condition
Condition	Dry skin
Classification by specialty	Dermatology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A study on the effects of Lactobacillus brevis SBC8803 intake on skin
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Transepidermal water loss
Key secondary outcomes	Moisture content of the stratum corneum, skin conditions, questionnaire(skin, feces), Athens insomnia scale, Pittsburgh sleep quality index(Japanese)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of placebo capsules for 12 consecutive weeks
Interventions/Control_2	Ingestion of capsules include Lactobacillus brevis SBC8803 50mg per a day for 12 consecutive weeks
Interventions/Control_3	Ingestion of capsules include Lactobacillus brevis SBC8803 25mg per a day for 12 consecutive weeks
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. Males and females between the ages of 20 and 59 2. Higher level of transepidermal water loss on arm
Key exclusion criteria	1. Subjects who have had lactobacillus-rich food, dietary supplements, or medicines constantly 2. Subjects who have used dietary supplements , medicines wchich affects skin constantly 3. Subjects who have treated cosmetic care 4. Subjects who treated cosmetic care except for measuring site or hormonal therapy 5. Subjects who got a facial, a wash-rag, lost hair, or plan these actions 6. Subjects who takes a medicine constantly 7. Subjects who plan to get a tan 8. Subjects who wash the body which provides strong skin irritation 9. Subjects who have a wound or a inflammatory disease 10. Subjects who diagnosed atopy or skin disorders 11. Subjects who have asthma or the possibility of asthma 12. Subjects who have a possibility of having hay fever and gettig a medicine, or is expecdted to develop a symptom of allergic states at the skin in the current study term 13. Subjects who feels to trouble by rough skin around a menstruates 14. Subjects who is employed on a pre-dawn shift or on night duty 15. Subjects who have diabetes, liver disease, kidney disease, or diseases wchich affects a secretion of sex hormones 16. Subjects who have participated in other clinical study 17. Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination 18. Subjects who plans to become pregnant or lactate 19. Subjects who plans to go overseas 20. Subjects who have taken a blood sample or donated blood beyond the limit rules within the last one year prior to the screening test 21. Subjects who take measures affecting the results in current study, or don't stick to the rules 22. Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 23. Subjects who are judged as unsuitable for the study by physician for other reason
Target sample size	120

Research contact person
Name of lead principal investigator	KONDO Sumio
Organization	Medical Corporation Kenshokai, Fukushima Healthcare Center
Division name	Internal medicine
Address	2-12-16, Tamagawa, Fukushima-ku, Osaka
TEL	06-6441-6848
Email	ko283434@ares.eonet.ne.jp

Public contact
Name of contact person	NAKAGAWA Takashi
Organization	Total Technological Consultant Co., Ltd.(TTC)
Division name	Clinical Research Planning Dept.
Address	1-20-2 Ebisu Nishi, Shibuya-ku, Tokyo, Seibu Shinyokinko Ebisu Bldg
TEL	03-5459-5329
Homepage URL
Email	t.nakagawa@ttc-tokyo.co.jp

Sponsor
Institute	Total Technological Consultant Co., Ltd.(TTC)
Institute
Department

Funding Source
Organization	SAPPORO HOLDINGS LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	SAPPORO BREWERIES LTD.
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

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 13 Day
Anticipated trial start date	2014 Year 03 Month 01 Day
Last follow-up date	2014 Year 06 Month 24 Day
Date of closure to data entry	2014 Year 07 Month 23 Day
Date trial data considered complete	2014 Year 07 Month 30 Day
Date analysis concluded	2014 Year 10 Month 16 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.spandidos-publications.com/etm/12/6/3863
Results	The results of the present study revealed that following the analysis of the whole populations, marginal differences were observed in TEWL (for example, suppression of skin water loss) at the neck in the 25 mg/day group at week 8 and at the lower eye region in the 50 mg/day group at week 4 (P=0.05 and 0.09, respectively, compared with the placebo group analyzed by Dunnett's test). A significant increase in corneal hydration was also observed at the neck in the 25 mg/day group at week 12 (P=0.06, as compared with the placebo group as analyzed by Dunnett's test). In the analysis of the subpopulations whose habitual frequency of taking lactic fermentation products was less than once per week, the levels of corneal hydration at the neck (in the 50 mg/day group) and lower eye region (in the 25 mg/day group) were significantly increased at week 12 (P<0.05). In conclusion, the results of the present investigation suggest that oral intake of heat killed L. brevis SBC8803 is effective at improving skin hydration conditions in populations with low habitual frequency of taking lactic fermentation products.
Other related information

Management information
Registered date	2014 Year 06 Month 20 Day
Last modified on	2016 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016678