UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051504 |
|---|---|
| Receipt number | R000058711 |
| Scientific Title | Effects of the intake of foods containing Bacillus natto on the intestinal environment and the skin condition |
| Date of disclosure of the study information | 2023/07/10 |
| Last modified on | 2025/01/06 08:22:53 |
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Basic information
Public title
Effects of the intake of foods containing Bacillus natto on the intestinal environment and the skin condition
Acronym
Effects of the intake of foods containing Bacillus natto on the intestinal environment and the skin condition
Scientific Title
Effects of the intake of foods containing Bacillus natto on the intestinal environment and the skin condition
Scientific Title:Acronym
Effects of the intake of foods containing Bacillus natto on the intestinal environment and the skin condition
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of the intake of foods containing Bacillus natto on the intestinal environment and the skin condition in healthy Japanese subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The transdermal moisture transpiration at 8 weeks after consumption
Key secondary outcomes
Stratum corneum moisture content, collagen score, skin viscoelasticity, fecal components, questionnaire (defecation, health condition, skin condition) at 8 weeks after consumption
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: Intake of Bacillus natto chewables (8 weeks), Washout period (more than 8 weeks), Intake of placebo chewables (8 weeks)
Administration: Take one chewable per day after the dinner.
Interventions/Control_2
Duration: Intake of placebo chewables (8 weeks), Washout period (more than 8 weeks), Intake of Bacillus natto chewables (8 weeks)
Administration: Take one chewable per day after the dinner.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese males and females aged over 18 years old at the time of informed consent.
2. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
none
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Takaoka |
Organization
Kobe College
Division name
School of Human Sciences
Zip code
662-8505
Address
4-1, Okadayama, Nishinomiya-city, Hyogo, Japan
TEL
0798-51-8423
takaoka@mail.kobe-c.ac.jp
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Takaoka |
Organization
Kobe College
Division name
School of Human Sciences
Zip code
662-8505
Address
4-1, Okadayama, Nishinomiya-city, Hyogo, Japan
TEL
0798-51-8668
Homepage URL
takaoka@mail.kobe-c.ac.jp
Sponsor or person
Institute
Kobe College
Institute
Department
Personal name
Funding Source
Organization
Ikeda Food Research 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
The ethical committee of school of human science, Kobe college
Address
4-1, Okadayama, Nishinomiya-city, Hyogo, Japan
Tel
0798-51-8423
sumi@mail.kobe-c.ac.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
| 2023 | Year | 07 | Month | 10 | 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
14
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
| 2023 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058711
