UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025888 |
|---|---|
| Receipt number | R000029762 |
| Scientific Title | Lactobacillus supplement intake test |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2018/06/21 17:33:53 |
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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
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
nishimaki@b-hr.jp
Sponsor or person
Institute
Beauty & Health Research_Inc
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029762
