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

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 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


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

Value
https://center6.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