UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059532 |
|---|---|
| Receipt number | R000067765 |
| Scientific Title | Verification of the Effects of Lactic Acid Bacteria Consumption on the Skin Quality of Healthy Individuals Who Recognize Having Sensitive Skin -A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study- |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/01/21 16:05:40 |
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Basic information
Public title
Verification of the Effects of Lactic Acid Bacteria Consumption on the Skin Quality of Healthy Individuals Who Recognize Having Sensitive Skin
-A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study-
Acronym
Verification of the Effects of Lactic Acid Bacteria Consumption on the Skin Quality of Healthy Individuals Who Recognize Having Sensitive Skin
Scientific Title
Verification of the Effects of Lactic Acid Bacteria Consumption on the Skin Quality of Healthy Individuals Who Recognize Having Sensitive Skin
-A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study-
Scientific Title:Acronym
Verification of the Effects of Lactic Acid Bacteria Consumption on the Skin Quality of Healthy Individuals Who Recognize Having Sensitive Skin
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of consuming the test food (lactic acid bacteria-containing food) on skin function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin moisture content
Key secondary outcomes
*Secondary Evaluation Items
1) Trans-epidermal water loss
2) Skin viscoelasticity
3) Visual assessment by specialist physician
4) Skindex 16 Japanese version (skin disease-specific QOL scale)
5) DLQI Japanese version (Dermatology Life Quality Index)
5) Perceived VAS questionnaire
6) Gut microbiota analysis
6) Fecal organic acid analysis
7) Specialized blood tests
*Safety Evaluation Items
1) Physical Examination (Blood Pressure/Pulse, Weight/Body Fat Percentage/BMI)
2) Laboratory Tests (Hematological Tests, Blood Biochemical Tests, Urinalysis)
3) Daily Activity Log
4) Physician Interview and Adverse Event Survey (Presence/Absence of Side Effects)
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
Oral ingestion of a test food (2 tablets in a day; 8 weeks).
Interventions/Control_2
Oral ingestion of a placebo food (2 tablets in a day; 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged 20 years or older but under 65 years at the time of obtaining consent to participate in the trial.
2) Healthy individuals without chronic physical diseases, including skin diseases.
3) Individuals with sensitive skin symptoms.
4) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this trial.
5) Individuals who can attend the designated examination date and undergo the examination.
6) Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria
Individuals
1) currently suffering from any disease and undergoing drug therapy.
2) undergoing hormone replacement therapy.
3) with skin disease symptoms such as atopic dermatitis.
4) with a history of ingesting or applying drugs for disease treatment within the past month.
5) with a history or current condition of serious disorders affecting the digestive organs, liver, kidneys, heart, lungs, blood, or mental health.
6) with a BMI of 30.0 kg/m2 or higher.
7) who may experience allergic reactions to components in the test food, or who may experience severe allergic reactions to other foods or pharmaceuticals.
8) who currently have, or have had within the past three months, a habit of continuously using lactic acid bacteria-enriched foods, foods for specified health uses claiming skin improvement effects, foods with functional claims, or health foods.
9) whose average weekly alcohol consumption exceeds 40 g/day for men or 20 g/day for women, converted to pure alcohol.
10) with a smoking habit
11) who may have night shifts or changes in lifestyle habits during the trial period.
12) who may experience symptoms such as itching on the evaluation sites (face, arms, back) due to seasonal allergy symptoms like hay fever during the trial period. Also, individuals who may take anti-allergy medications or use nasal sprays (eye drops are acceptable).
13) unable to refrain from intentional exposure to direct sunlight, such as sunbathing, during the trial period.
14) with a history of cosmetic procedures or treatments on the evaluation sites within the past 6 months.
15) who are pregnant, breastfeeding, or may become pregnant during the trial period.
16) currently participating in another human clinical trial, or individuals who have not completed participation in another human clinical trial within the past 3 months.
17) Other individuals deemed ineligible for this trial by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Motoyuki |
| Middle name | |
| Last name | Tagashira |
Organization
Asahi Group Foods, Ltd.
Division name
Research and Development Headquarters
Zip code
302-0106
Address
1-1-21 Midori, Moriya-shi, Ibaraki, Japan
TEL
080-7789-1291
motoyuki.tagashira@asahi-gf.co.jp
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
Asahi Group Foods, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Metagen, Inc.
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 17 | 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 | 10 | Month | 24 | Day |
Last modified on
| 2026 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067765
