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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025566
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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