UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effects of oral intake of lactic acid bacteria on skin condition. A randomized, double-blind, placebo-controlled trial.
Title of the study (Brief title)	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	Takahiro Ono
Organization	Medical Corporation Wakei-kai Medics Hongo Clinic
Division name	Director
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	Takashi Fujitomo
Organization	DeNA Life Science, Inc.
Division name	Business Planning Dept.
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
Institute	DeNA Life Science, Inc.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029417