UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014327 |
|---|---|
| Receipt number | R000016678 |
| Scientific Title | A study on the effects of Lactobacillus brevis SBC8803 intake on skin in adults |
| Date of disclosure of the study information | 2014/06/20 |
| Last modified on | 2016/12/09 17:29:59 |
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Basic information
Public title
A study on the effects of Lactobacillus brevis SBC8803 intake on skin in adults
Acronym
A study on the effects of Lactobacillus brevis SBC8803 intake on skin
Scientific Title
A study on the effects of Lactobacillus brevis SBC8803 intake on skin in adults
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | KONDO Sumio |
Organization
Medical Corporation Kenshokai, Fukushima Healthcare Center
Division name
Internal medicine
Zip code
Address
2-12-16, Tamagawa, Fukushima-ku, Osaka
TEL
06-6441-6848
ko283434@ares.eonet.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | NAKAGAWA Takashi |
Organization
Total Technological Consultant Co., Ltd.(TTC)
Division name
Clinical Research Planning Dept.
Zip code
Address
1-20-2 Ebisu Nishi, Shibuya-ku, Tokyo, Seibu Shinyokinko Ebisu Bldg
TEL
03-5459-5329
Homepage URL
t.nakagawa@ttc-tokyo.co.jp
Sponsor or person
Institute
Total Technological Consultant Co., Ltd.(TTC)
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.spandidos-publications.com/etm/12/6/3863
Number of participants that the trial has enrolled
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.
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
| 2014 | Year | 02 | Month | 13 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016678
