UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034061 |
|---|---|
| Receipt number | 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 | 2019/10/25 13:14:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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 | Takahiro |
| Middle name | |
| Last name | Ono |
Organization
Ueno Asagao Clinic
Division name
Director
Zip code
110-0015
Address
Kairaku Building 6th floor, 2-7-5, Higashiueno, Taito-ku, Tokyo, Japan
TEL
03-6240-1162
info@ueno-asagao.clinic
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | amura |
Organization
TES holdings Co., Ltd.
Division name
Division of Clinical Research Business
Zip code
110-0015
Address
Kairaku Building 6th floor, 2-7-5, Higashiueno, Taito-ku, Tokyo, Japan
TEL
03-6801-8480
Homepage URL
t.tamura@tes-h.co.jp
Sponsor or person
Institute
TES holdings Co., Ltd.
Institute
Department
Personal name
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
Ethics Committee of the Oriental Ueno Detection Center
Address
1-20-11, Ueno, Taito-ku, Tokyo, Japan
Tel
03-5816-0711
info@tes-h.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
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
70
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
| 2018 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
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
| 2019 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.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 |
