UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058320 |
|---|---|
| Receipt number | R000066623 |
| Scientific Title | Effects of Continuous Ingestion of Probiotics on Skin Condition:A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study. |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/06/30 17:18:01 |
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Basic information
Public title
Effects of Continuous Ingestion of Probiotics on Skin Condition:A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study.
Acronym
Effects of Continuous Ingestion of Probiotics on Skin Condition
Scientific Title
Effects of Continuous Ingestion of Probiotics on Skin Condition:A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study.
Scientific Title:Acronym
Effects of Continuous Ingestion of Probiotics on Skin Condition
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous ingestion of probiotics on facial condition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
transepidermal water loss
Key secondary outcomes
stratum corneum water content, fecal metabolites
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
Ingestion of test powder containing probiotics for a duration of 8 weeks.
Interventions/Control_2
Intake of placebo powder for a duration of 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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1)Subjects aged between 35 and 59 years
2)Subjects with skin concerns such as dry skin
Key exclusion criteria
1)Subjects with any chronic disease undergoing medication
2)Subjects with skin diseases, skin needing treatment, or diseases affecting skin
3)Subjects with serious drug/food allergies or a history of them
4)Subjects with malignant tumors, respiratory, liver, renal, cardiac, pulmonary, gastrointestinal, hematologic, endocrine, and metabolic diseases, or history of them
5)Subjects undergoing cosmetic procedures affecting skin, or using strong moisturizing/wrinkle effect cosmetics
6)Subjects habitually consuming food for specified health uses, functional foods, medicines or supplements that affect skin
7)Subjects habitually consuming foods/drinks affecting skin
8)Subjects regularly consuming foods/supplements with lactobacilli, bifidobacteria, oligosaccharides or affecting the intestinal environment
9)Subjects intentionally exposing themselves to sunlight during the test like sunbathing
10)Subjects with a habit of drinking large amounts of alcohol(20g or more/day of pure alcohol)
11)Subjects with a smoking habit
12)Subjects with a BMI under 17kg/m2 or 30kg/m2 or more
13)Subjects defecating under three times a week
14)Subjects with chronic gastrointestinal symptoms like diarrhea
15)Subjects regularly taking medications including laxatives, intestinal regulators, and purgatives
16)Subjects who have taken antibiotics for a week or more in three months prior to the pre-test
17)Subjects with cosmetic procedures/treatments on evaluated areas in two months prior to the pre-test, or during the test
18)Subjects with scars or inflammation on evaluation area, or regular skin irritation there like pre/post menstruation
19)Subjects with irregular lifestyles
20)Subjects planning lifestyle changes during the test
21)Subjects pregnant, planning pregnancy during the test, or breastfeeding
22)Subjects in other drug/food tests in three months prior to the pre-test or scheduled to participate in these tests
23)Subjects judged unsuitable by principal or subinvestigator based on background
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinic
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@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
| 2025 | Year | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066623
