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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025951
Receipt No. 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

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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
Email 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
Email k_masuda@mail.souken-r.com

Sponsor
Institute SOUKEN Co., Ltd.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029834

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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