UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059125 |
|---|---|
| Receipt number | R000067632 |
| Scientific Title | A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of continuous probiotics intake on protecting the skin from UV damage. |
| Date of disclosure of the study information | 2025/09/18 |
| Last modified on | 2025/09/18 18:06:42 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of continuous probiotics intake on protecting the skin from UV damage.
Acronym
A study of the effects of probiotics on protecting the skin from UV damage.
Scientific Title
A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of continuous probiotics intake on protecting the skin from UV damage.
Scientific Title:Acronym
A study of the effects of probiotics on protecting the skin from UV damage.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous probiotic ingestion in protecting skin from UV damage in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Minimal erythema dose (MED)
Key secondary outcomes
Skin color (a*)
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
Intake of test foods for 8 weeks.
Interventions/Control_2
Intake of placebo foods 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) Participants aged 30 to 59 years at the time of obtaining consent.
2) Participants whose Fitzpatrick skin phototype is type II or III.
3) Participants whose dorsal skin allows for the evaluation of minimum erythema dose (MED), and who were judged to have MED in the second to sixth levels of UV radiation at the screening.
4) Participants who are able to visit the test site on all test days.
Key exclusion criteria
1) Participants with photosensitivity disorder.
2) Participants taking medicines affecting the skin sensitivity to light.
3) Participants continuously taking anti-inflammatory medicines at least once a month.
4) Participants undergoing cosmetic treatments affecting the skin, or potent cosmetics.
5) Participants habitually consuming items affecting the skin.
6) Participants with skin conditions or damage, including scars, inflammation or regular skin irritation on their dorsal skin, such as pre/post menstruation.
7) Participants who have been exposed to UV rays beyond daily life during the two months prior to the screening, or cannot refrain from excessive UV exposure during the study period.
8) Participants with serious drug/food allergies or a history of them.
9) Participants currently under treatment or with a history of serious symptoms from malignant tumors or disorders of respiratory, liver, kidney, heart, lung, digestive, blood, endocrine, or metabolic systems.
10) Participants habitually consuming items with lactobacilli, bifidobacteria, oligosaccharides or affecting the intestinal environment.
11) Participants habitually drinking excessive alcohol.
12) Participants with a smoking habit.
13) Participants with a BMI under 17.0 kg/m2 or 28.0 kg/m2 or more.
14) Participants with fewer than three bowel movements per week.
15) Participants with chronic gastrointestinal symptoms such as diarrhea.
16) Participants with irregular lifestyles.
17) Participants planning lifestyle changes, or visit areas with strong UV rays during the study period.
18) Participants who are pregnant, breastfeeding, or planning pregnancy during the study period.
19) Participants who have participated in other studies three months prior to the date of consent, scheduled to participate in studies, or have traces of sunburn on the dorsal skin from previous studies.
20) Participants judged ineligible by principal investigator based on their background.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Wakako |
| Middle name | |
| Last name | Inoue |
Organization
YAWARA Dermatology Clinic
Division name
Director
Zip code
530-0041
Address
The 9th Tabuchi Building 4F, 5-7-10 Tenjinbashi, Kita-ku, Osaka, Japan
TEL
06-6882-1130
yuyosei@drc-web.co.jp
Public contact
Name of contact person
| 1st name | Yuhma |
| Middle name | |
| Last name | Yoshida |
Organization
DRC Co., Ltd.
Division name
Efficacy Testing of Cosmetics and Foods Group
Zip code
530-0044
Address
The 9th Tabuchi Building 3F, 2-10-31 Higashi-Temma, Kita-ku, Osaka, Japan
TEL
06-6882-8201
Homepage URL
yoshida@drc-web.co.jp
Sponsor or person
Institute
DRC 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
Brain Care Clinic Ethics Review Committee.
Address
Shiratori Building 2F,2-1-2 Shinjuku, Shinjuku-ku, Tokyo
Tel
06-6882-1130
ethics_board@drc-web.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
DRCクリニック（大阪府）
（DRC Clinic（Osaka））
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 18 | 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 | 09 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2025 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067632
