UMIN-CTR Clinical Trial

Public title

Study of the effects of lactic acid bacteria intake on skin condition and inflammation-related markers in adult men and women with atopic predisposition

Acronym

Study of the effects of lactic acid bacteria intake on skin condition and inflammation-related markers in adult men and women with atopic predisposition

Scientific Title

Study of the effects of lactic acid bacteria intake on skin condition and inflammation-related markers in adult men and women with atopic predisposition

Scientific Title:Acronym

Study of the effects of lactic acid bacteria intake on skin condition and inflammation-related markers in adult men and women with atopic predisposition

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effects of lactic acid bacteria-containing foods on skin condition and inflammation-related markers during 8 weeks of continuous intake.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Skin measurement (stratum corneum water content, transepidermal water loss, color difference (a *, L *))
QOL questionnaire (SKINDEX16, DLQI, SF-36, VAS questionnaire)
Evaluate before, 4 weeks and 8 weeks after intake.

Key secondary outcomes

Inflammation-related markers
Evaluate before, 4 weeks and 8 weeks after intake.

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

2 grains of the test product daily oral intake for 8 weeks.

Interventions/Control_2

2 grains of the placebo daily oral intake 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

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Men and women between the ages of 20 and 64.
(2) Subjects who are aware of itching due to dry skin.
(3) Subjects who are judged by a doctor that treatment for atopic dermatitis is not necessary.
(4) Subjects who fall under any one or more of the following atopic predispositions
A: Relatives or subjects fall under any of the following
･Relatives (within 3rd degree) have a history of or are currently suffering from bronchial asthma, allergic rhinitis, conjunctivitis, atopic dermatitis, or more.
･Subject has a history of bronchial asthma, allergic rhinitis, conjunctivitis, atopic dermatitis, or more than one, and is not currently receiving treatment.
B: Easy to produce IgE antibody

Key exclusion criteria

(1) Subjects who regularly use foods rich in lactic acid bacteria, health foods, and medicines at least three times a week.
(2) Subjects who routinely take health foods that may affect the test results.
(3) Subjects with experience in aesthetic medicine that affect the measurement site.
(4) Subjects who received aesthetic medicine or hormone replacement therapy other than the measurement site from one year ago.
(5) Subjects who have undergone esthetic treatment, scrubbing, or hair loss on the skin at the measurement site from one month ago to the end of the study.
(6) Subjects who plan to get a sunburn due to long hours of outdoor work, etc. from one month ago to the end of the study.
(7) Subjects who have a habit of washing their bodies by giving a strong stimulus to the measurement site.
(8) Subjects who regularly use bath salts or subjects who have a habit of taking a hot spring at a frequency of 1 day or more a month.
(9) Subjects with skin disorders at the measurement site.
(10) Subjects who feel that rough skin occurs at the measurement site before and after menstruation.
(11) Night and day shift worker.
(12) Subjects who plan to travel abroad during the research period.
(13) Subjects who have serious diseases, or diseases that affect the secretion of sex hormones, or have a history thereof.
(14) Subjects who may develop allergic-like symptoms with research foods.
(15) Subjects with a disease under treatment that affects the evaluation of this study, or with a history of serious illness.
(16) Subjects whose pre-examination test values are significantly out of the reference range.
(17) Subjects who have participated in other clinical studies within one month or will participate in.
(18) Subjects who are planned to become pregnant or are pregnant or lactating.
(19) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(20) Subjects judged as unsuitable for the study by the investigator.

Target sample size

44

Name of lead principal investigator

1st name	Sumio
Middle name
Last name	Kondo

Organization

Medical Corporation Kenshokai Fukushima Healthcare Center

Division name

Head

Zip code

553-0004

Address

2-12-16, Tamagawa, Fukushima-ku, Osaka-shi, Osaka

TEL

06-6441-6848

Email

drc_shokuhin@drc-web.co.jp

Name of contact person

1st name	Keiji
Middle name
Last name	Yamamoto

Organization

EP Mediate Co., Ltd.

Division name

Foods Department, Trial Planning Section

Zip code

162-0822

Address

Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo

TEL

070-3023-8214

Homepage URL

Email

yamamoto.keiji799@eps.co.jp

Institute

EP Mediate Co., Ltd.

Institute

Department

Personal name

Organization

Nissin Foods Holdings Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguroku, Tokyo

Tel

03-6452-2712

Email

nakagawa.akiko297@eps.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

12

Month

01

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

2021

Year

10

Month

28

Day

Date of IRB

2021

Year

10

Month

28

Day

Anticipated trial start date

2021

Year

12

Month

02

Day

Last follow-up date

2022

Year

03

Month

16

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

12

Month

01

Day

Last modified on

2022

Year

12

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052747