UMIN-CTR Clinical Trial

Basic information
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
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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.

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	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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	EP Mediate Co., Ltd.
Institute
Department

Funding Source
Organization	Nissin Foods Holdings 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	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
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	2021 Year 12 Month 01 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	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
Other related information

Management information
Registered date	2021 Year 12 Month 01 Day
Last modified on	2022 Year 12 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052747