UMIN-CTR Clinical Trial

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

None (Healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES

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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

DeNA Life Science, Inc.

Institute

Department

Personal name

Organization

Kirin Company, Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2018

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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