UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025566
Receipt number R000029417
Scientific Title A study for evaluating the effects of oral intake of lactic acid bacteria on skin condition. A randomized, double-blind, placebo-controlled trial.
Date of disclosure of the study information 2018/03/31
Last modified on 2018/01/13 12:24:02

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Basic information

Public title

A study for evaluating the effects of oral intake of lactic acid bacteria on skin condition. A randomized, double-blind, placebo-controlled trial.

Acronym

A study for evaluating the effects of oral intake of lactic acid bacteria on skin condition.

Scientific Title

A study for evaluating the effects of oral intake of lactic acid bacteria on skin condition. A randomized, double-blind, placebo-controlled trial.

Scientific Title:Acronym

A study for evaluating the effects of oral intake of lactic acid bacteria on skin condition.

Region

Japan


Condition

Condition

None (Healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the efficacy of oral administration of a lactic acid bacteria on skin conditions.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Analysis of skin microbiome (8 weeks)

Key secondary outcomes

Evaluation of skin condition by medical doctor (8 weeks)
Analysis of expression level of skin-condition-related genes (8 weeks)
Trans-epidermal water loss (8 weeks)
Skin moisture content (8 weeks)
VISIA skin analysis (8 weeks)
Questionaries (4 weeks,8 weeks)


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

Prevention

Type of intervention

Food

Interventions/Control_1

Lactic acid bacteria, 1 portion of food per day for 8 weeks.

Interventions/Control_2

Placebo (not containing lactic acid bacteria), 1 portion of food per day for 8 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

30 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

1) Males and females aged from 30 to less than 60 years old, when giving the informed consent.
2) Healthy individuals not having any chronic disedase or dermatoses.
3) Individuals who have skin problesms, such as acne.
4) Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
5) Individuals who can accomplish their tasks in the study at the appointed date.
6) Individuals who are judged suitable for this study by the investigators.

Key exclusion criteria

1) Individuals who have diseases with medications.
2) Individuals who have continuously received medications within one month before the examination.
3) Individuals who have medical histories of serious disease of their liver, kidney, heart, lung, and blood.
4) Individuals who have comorbidity or medication history in their digestive organs.
5) Individuals whose systolic blood pressure is over 160 mmHg, or whose diastolic blood pressure is over 100 mmHg.
6) Individuals who have sever skin disorder.
7) Individuals who have severe anemia.
8) Individuals who might be allergic to test foods, or who might be seriously allergic to other foods, or medicaments.
9) Individuals who are pregnant, breastfeeding, or planning to be pregnant.
10) Individuals who are alcoholic or have mental disorder.
11) Individuals who will change their life style during the test period.
12) Individuals who have skin disease and need the application of medicine containing steroids or antibiotics to their face.
13) Individuals who have severe menopausal symptoms.
14) Individuals who cannot stop eating foods containing lactic acid bacteria.
15) Individuals who continuously took medicines for skin-condition-improvement within the last three month.
16) Individuals who use cosmetics that have strong effects on skin moisture or wrinkles.
17) Individuals who cannot keep from outdoor activities with the risk of getting sunburned during the test.
18) Individuals who had a surgery in their face within the past 6 months.
19) Individuals who are participating or participated in another clinical trial within the last 3 months.
20) Individuals who and whose family work for a company manufacturing or selling healthy foods, functional foods, and cosmetics.
21) Individuals who have smoking habitat.
22) Individuals who are judged unsuitable for this study by the investigator for other reasons.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takahiro Ono

Organization

Medical Corporation Wakei-kai Medics Hongo Clinic

Division name

Director

Zip code


Address

ESTO HONGO, 2-2-6, Mukougaoka, Bunkyo-ku, Tokyo, 1130023, JAPAN

TEL

03-6801-9761

Email

hongo@wakei-kai.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Fujitomo

Organization

DeNA Life Science, Inc.

Division name

Business Planning Dept.

Zip code


Address

Shibuya-Hikarie, 2-21-1, Shibuya, Shibuya-Ku, Tokyo, Japan

TEL

03-4366-7219

Homepage URL


Email

Takashi.fujitomo@dena-ls.co.jp


Sponsor or person

Institute

DeNA Life Science, Inc.

Institute

Department

Personal name



Funding Source

Organization

Kirin Company, Limited

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

医療法人社団和啓会 メディクス本郷クリニック/ Medical Corporation Wakei-kai Medics Hongo Clinic


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 31 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 11 Month 29 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 11 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 06 Day

Last modified on

2018 Year 01 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029417


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name