UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of effect of Lactobacillus plantarum 22A-3 on improvement of skin and bowel conditions
Title of the study (Brief title)	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	Takashi Koikeda
Organization	Shiba Palace Clinic
Division name	Hospital director
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	Ko Masuda
Organization	SOUKEN Co., Ltd.
Division name	Management division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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