UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045596 |
|---|---|
| Receipt number | R000052045 |
| Scientific Title | Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy in bifidobacteria on skin aging in healthy women |
| Date of disclosure of the study information | 2021/09/28 |
| Last modified on | 2025/12/04 20:20:54 |
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Basic information
Public title
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy in bifidobacteria on skin aging in healthy women
Acronym
A clinical study of oral probiotics intake and skin aging
Scientific Title
Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy in bifidobacteria on skin aging in healthy women
Scientific Title:Acronym
A clinical study of oral bifidobacteria intake and skin aging
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the change of skin aging signs and the balance of both skin and gut microflora after 12 weeks of oral intake of bifidobacteria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VISIA total score after oral intake of bifidobacteria
Key secondary outcomes
VISIA sub-scores, the balance of gut microbiota, the balance of skin microbiota, objective evaluation of skin condition, subjective evaluation of skin condition(VAS) after oral intake of bifidobacteria
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
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of powdered bifidobacteria for 12 weeks
Interventions/Control_2
Intake of powdered placebo for 12 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
| Not applicable |
Gender
Female
Key inclusion criteria
Adult female aged 30 years old or older
Key exclusion criteria
Individual who is applicable to any of the conditions below;
1. Taking regular aesthetic procedure or foods (except those who are able to continuously discontinue the act during the study).
2. Having skin problems, requiring medical care to their skin or taking treatment to diseases that could have an influence on their skin.
3. Having major allergic disease or being highly likely to develop those diseases
4. Being under sever diseases or having past history of those diseases.
5. Having medication allergy or severe food allergy.
6. Regularly taking foods, medication or supplement that would have an influence on gut microbiota (4 or more days a week of intake is regarded as regular use).
7. Heavy drinker
8. Smoking more than 20 cigarettes a day
9. Pregnant, willing to pregnant during the study period and continuous breast feeding
10. Currently participating to other clinical trial or past history within a month
11. Judged as not appropriate to this study by a responsible doctor or contributing doctors
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Yuriko |
| Middle name | |
| Last name | Nishikawa |
Organization
Juntendo university graduate school of medicine
Division name
Department of Microbiota Research
Zip code
113-0033
Address
3-3-1 Ochanomizu KS Building 405, Hongo, Bunkyo-ku, Tokyo
TEL
03(3813)3111
ynishika@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Nishikawa |
Organization
Juntendo university graduate school of medicine
Division name
Department of Microbiota Research
Zip code
113-0033
Address
3-3-1 Ochanomizu KS Building 405, Hongo, Bunkyo-ku, Tokyo
TEL
03(3813)3111
Homepage URL
ynishika@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university graduate school of medicine
Department of Microbiota Research
Institute
Department
Personal name
Funding Source
Organization
A joint research department between Juntendo University Graduate School of Medicine and Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
The Jikei University Kashiwa hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
1-13-23 Minami-ikebukuro, Toshima-ku, Tokyo 171-0022
Tel
03(6868)7022
http://www.jccr.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
| 2021 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/17/18/2976
Publication of results
Unpublished
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/17/18/2976
Number of participants that the trial has enrolled
120
Results
The total VISIA score worsened in the placebo group at week 8 (p=0.029) but not in the B. breve group. Compared with that of the placebo group, the brown spot score of the B. breve group improved at weeks 4 (p=0.013) and 8 (p=0.041), and the pore score improved at weeks 4 (p=0.013), 8 (p=0.041) and 12 (p=0.004). Genus-level analysis of the gut microbiota revealed a significant increase in Blautia abundance in the B. breve group. The frequency of adverse events was not different between the groups.
Results date posted
| 2025 | Year | 12 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
120 women between the ages of 30 and 79 years were recruited. No significant differences in baseline background characteristics were observed between the two groups.
Participant flow
One participant in the placebo group was excluded because of the use of antibiotics prior to the consumption of the study food, and 119 participants completed the 12-week study (59 participants in the B. breve group and 60 participants in the placebo group).
Adverse events
Adverse events occurred in 37.0% of the participants in total. The most common symptoms were dermatological problems such as acne, flu symptoms and gastrointestinal symptoms, including diarrhoea. The occurrence of adverse events did not differ between the groups. All adverse events were mild and transient and were not related to the intake of the study foods.
Outcome measures
VISIA scores, skin condition scored by physician, subjective scores (VAS scores, skin and stool conditions)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 08 | 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
| 2021 | Year | 09 | Month | 28 | Day |
Last modified on
| 2025 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052045
