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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034061
Receipt No. R000038825
Scientific Title A study for the effect of microorganism containing foods on skin condition. A randomized, double-blind, placebo-controlled, Parallel-group comparison trial.
Date of disclosure of the study information 2018/09/25
Last modified on 2018/09/07

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Basic information
Public title A study for the effect of microorganism containing foods on skin condition. A randomized, double-blind, placebo-controlled, Parallel-group comparison trial.
Acronym A study for the effect of microorganism containing foods on skin condition
Scientific Title A study for the effect of microorganism containing foods on skin condition. A randomized, double-blind, placebo-controlled, Parallel-group comparison trial.
Scientific Title:Acronym A study for the effect of microorganism containing foods on skin condition
Region
Japan

Condition
Condition None (Healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of microorganism containing foods on skin conditions
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes - Analysis of skin microbiome
- Analysis of expression level of skin-condition-related genes
Key secondary outcomes - Evaluation of skin condition by medical doctor
- Skin color difference (LAB value)
- Trans-epidermal water loss
- Skin moisture content
- VISIA skin analysis
- Questionnaires

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 Microorganism containing food (capsule form), once a day for 8 weeks
Interventions/Control_2 Microorganism not containing food (capsule form), once a 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
20 years-old <=
Age-upper limit
45 years-old >
Gender Female
Key inclusion criteria 1)Healthy Japanese females aged from 20 to less than 45 years old, when giving the informed consent.
2)Healthy individuals not having any chronic disease.
3)Individuals whose skin bacteria can be detected from forehead.
4)Individuals who generally have skin problems.
5)Individuals who are working more than 3 days per week.
6)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.
7)Individuals who can accomplish their tasks in the study at the appointed date.
8)Individuals who are judged suitable for this study by the investigators.
Key exclusion criteria 1)Individuals who have diseases with medications.
2)Individuals who receive medications within 1 month before examination.
3)Individuals who have a medical history of serious disease of liver, kidney, heart, lung, blood and digestive tract.
4)Individuals who have severe skin disorder, such as skin burn.
5)Individuals who are difficult to take samples for gene expression analysis.
6)Individuals who refuse to disclose their biological sexes.
7)Individuals who may have an allergic symptom to test foods, or individuals who may have a serious allergic symptom to other foods, or medicaments.
8)Individuals who are alcoholic or have mental disorders.
9)Individuals who have a smoking habitat.
10)Individuals who will change their life style during test period, such as traveling for a long period.
11)Individuals who cannot keep from direct sunlight exposure, such as tanning activities, during test period.
12)Individuals who may occur seasonal allergic symptoms, such as hay fever, and receive medications during test period.
13)Individuals who have severe menopausal symptoms.
14)Individuals who are taking or took foods or medications, specified for skin conditions or are planning to take these foods during test period.
15)Individuals who cannot stop eating foods related with this test foods during test period.
16)Individuals who have severe anemia.
17)Individuals who donate more than 200 ml of blood within 1 month or more than 400 ml of blood within 3 months.
18)Individuals who have a surgical or treatment history on the regions of measurement within 6 months.
19)Individuals who are pregnant, breastfeeding, or planning to be pregnant in the near future.
20)Individuals who are participating or participated in another clinical trial within the last 3 months.
21)Individuals who and whose family living with them work for a company manufacturing or selling healthy foods or cosmetics.
22)Individuals who are judged as unsuitable for participating this study by the investigator.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Ono
Organization Ueno Asagao Clinic
Division name Director
Zip code
Address Kairaku Building 6th floor, 2-7-5, Higashiueno, Taito-ku, Tokyo, Japan
TEL 03-6240-1162
Email info@ueno-asagao.clinic

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyasu Tamura
Organization TES holdings Co., Ltd.
Division name Division of Clinical Research Business
Zip code
Address Kairaku Building 6th floor, 2-7-5, Higashiueno, Taito-ku, Tokyo, Japan
TEL 03-6801-8480
Homepage URL
Email t.tamura@tes-h.co.jp

Sponsor
Institute TES holdings Co., Ltd.
Institute
Department

Funding Source
Organization Kirin 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
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 うえのあさがおクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 25 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 No longer recruiting
Date of protocol fixation
2018 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 26 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
2018 Year 09 Month 07 Day
Last modified on
2018 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038825

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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