UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025951 |
|---|---|
| Receipt number | R000029834 |
| Scientific Title | Evaluation of effect of Lactobacillus plantarum 22A-3 on improvement of skin and bowel conditions |
| Date of disclosure of the study information | 2017/03/06 |
| Last modified on | 2017/08/25 17:03:18 |
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Basic information
Public title
Evaluation of effect of Lactobacillus plantarum 22A-3 on improvement of skin and bowel conditions
Acronym
Evaluation of effect of Lactobacillus plantarum 22A-3 on improvement of skin and bowel conditions
Scientific Title
Evaluation of effect of Lactobacillus plantarum 22A-3 on improvement of skin and bowel conditions
Scientific Title:Acronym
Evaluation of effect of Lactobacillus plantarum 22A-3 on improvement of skin and bowel conditions
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of effect of Lactobacillus plantarum 22A-3 on skin and bowel conditions in healthy human
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of skin condition(Color difference, transepidermal water loss, skin hydration) and defection after intervention
Key secondary outcomes
questionnaires
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
Intake of test food (1 capsul/day, 4 weeks)
Interventions/Control_2
Intake of placebo food (1 capsul/day, 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)Japanese males and females aged 20-59 years
2)Subjects who are concerned about their dry skin
3)Subjects who are concerned about their rough skin
4)Subjects who are concerned about rough skin due to drying etc. to any of measurement region every year from October to March
5)Subjects who can abstain
6)Subjects whose written informed consent has been obtained
7)Subjects with 3-5 defections/week
Key exclusion criteria
1)Subjects who are usually take functional foods which would affect this study
2)Subjects who may show skin allergies symptoms and with skin hypersensitivity
3)Subjects who are likely to have allergy symptoms depending on the test food
4)Subjects who have the skin symptom such as a wound, an eruption, a wart, a burn, art make around the corner of the eye
5)Subjects who regularly go to dermatology hospital
6)Subjects who pregnant or lactating
7)Subjects who participates in the other clinical study
8)Subjects who regularly use drug which affect this study
9)Subjects who use Mesaic, Eye tape, or Eylash extention
10)Subjects who judged as unsuitable for the study by the investigator
11)Subjects who have abnormality in the skin of the measurement region
12)Subjects who suffers pollen allergy and taking medicine
13)Subjects who have chronic skin symptoms such as atopic dermatitis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Koikeda |
Organization
Shiba Palace Clinic
Division name
Hospital director
Zip code
Address
6F Daiwa A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
TEL
03-5408-1599
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ko Masuda |
Organization
SOUKEN Co., Ltd.
Division name
Management division
Zip code
Address
3F Daiwa A Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
TEL
03-5408-1555
Homepage URL
k_masuda@mail.souken-r.com
Sponsor or person
Institute
SOUKEN Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Maruzen pharmaceuticals 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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2016 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 06 | 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 | 02 | Month | 01 | Day |
Last modified on
| 2017 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029834
