UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062006 |
|---|---|
| Receipt number | R000070951 |
| Scientific Title | Continuous Intake of Lactobacillus Fermentation Products for Maintaining Physical Condition in College Students During Academic Examination Periods: A Pilot Exploratory Study |
| Date of disclosure of the study information | 2026/10/30 |
| Last modified on | 2026/06/22 17:45:59 |
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Basic information
Public title
Continuous Intake of Lactobacillus Fermentation Products for Maintaining Physical Condition in College Students During Academic Examination Periods: A Pilot Exploratory Study
Acronym
Continuous Intake of Lactobacillus Fermentation Products for Maintaining Physical Condition in College Students During Academic Examination Periods: A Pilot Exploratory Study
Scientific Title
Continuous Intake of Lactobacillus Fermentation Products for Maintaining Physical Condition in College Students During Academic Examination Periods: A Pilot Exploratory Study
Scientific Title:Acronym
Continuous Intake of Lactobacillus Fermentation Products for Maintaining Physical Condition in College Students During Academic Examination Periods: A Pilot Exploratory Study
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of the intake of Lactobacillus fermentation products on maintaining physical conditions under examination stress.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation by physical condition questionnaire
Key secondary outcomes
Saliva test (immune function indicators)
Evaluation by questionnaire on quality of life
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 food for 8 weeks
Interventions/Control_2
Intake of placebo food 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Healthy sixth-year students at the Tokushima University school of medicine who are scheduled to take the National Medical Practitioners Qualifying Examination
2.Subjects who provide consent to use the saliva testing service
3.Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the present study and being able to sign a written informed consent
Key exclusion criteria
1.Subjects who have a disease and go to a hospital or undergoing treatment
2.Subjects taking medication regularly during the study period
3.Subjects who smoke
4.Subjects with milk allergies
5.Subjects who are pregnant, or who plan or wish to become pregnant during the study period
6.Subjects who are unable to discontinue the intake of health foods that affect immune function during the study period
7.Subjects who participated in other clinical trials in one month or who plan to participate in other clinical trials during the study period
8.Subjects who know in advance that they will not be able to participate for the entire duration of the study
9.Subjects deemed unsuitable for the present study by the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kensei |
| Middle name | |
| Last name | Nishida |
Organization
Tokushima University
Division name
Dept. of Medical Education, Inst. of Biomedical Sciences
Zip code
7708503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9104
knishida@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kensei |
| Middle name | |
| Last name | Nishida |
Organization
Tokushima University
Division name
Dept. of Medical Education, Inst. of Biomedical Sciences
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9104
Homepage URL
knishida@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Meiji 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 Ethics Committee of Tokushima University Hospital
Address
2-50-1, Kuramoto-cho, Tokushima-shi, Tokushima, JAPAN
Tel
088-615-8512
first-ec@tokushima-u.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
| 2026 | Year | 10 | 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
| 2026 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 06 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070951
