UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062600 |
|---|---|
| Receipt number | R000071490 |
| Scientific Title | Safety Study of Overdoses of Echizen-cheese starter lactic acid bacterium. |
| Date of disclosure of the study information | 2026/08/19 |
| Last modified on | 2026/08/18 12:58:10 |
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Basic information
Public title
Safety Study of Overdoses of Echizen-cheese starter lactic acid bacterium in Healthy Participants.
Acronym
Safety Study of Overdoses of Echizen-cheese starter lactic acid bacterium.
Scientific Title
Safety Study of Overdoses of Echizen-cheese starter lactic acid bacterium.
Scientific Title:Acronym
Safety Study of Overdoses of Echizen-cheese starter lactic acid bacterium.
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will evaluate the safety of consuming excessive amounts of the test food in healthy adults.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1)Adverse events
2)Side effects
3)Physical examination
4)Biochemical examination
5)Facal test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
One treatment cycle will consist of 31 days. Anthropometric measurements, medical interviews, biochemical tests, and fecal sample collection will be conducted during the first 3 days. Participants will then consume capsules containing freeze-dried lactic acid bacteria powder (10^9 CFU per capsule) for the following 28 days, after which the same anthropometric measurements, medical interviews, biochemical tests, and fecal sample collection will be performed.
Interventions/Control_2
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Individuals who fully understand the nature and purpose of the study and provide written informed consent to participate.
Key exclusion criteria
Individuals meeting any of the following criteria will be excluded from the study:
-Individuals with an allergy to dairy products.
-Individuals with gastrointestinal disorders, such as inflammatory bowel disease or irritable bowel syndrome.
-Individuals with HIV infection or primary immunodeficiency; individuals currently receiving chemotherapy or radiotherapy for a malignant tumor; or individuals who are receiving continuous treatment with immunosuppressive drugs, including corticosteroids.
-Individuals who have been diagnosed with valvular heart disease or who have a prosthetic heart valve.
-Individuals with diabetes mellitus or elevated blood glucose levels.
-Individuals who use or plan to use antibiotics, antifungal agents, or intestinal microbiota-modulating agents during the study period.
-Individuals who follow any dietary restrictions for medical or religious reasons.
-Individuals who are pregnant, breastfeeding, or planning to become pregnant.
-Individuals deemed unsuitable for participation in the study by the principal investigator or the attending physician for any other reason.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | HIBI |
Organization
Fukui Prefectural University
Division name
Faculty of Bioscience and Biotechnology
Zip code
910-1195
Address
4-1-1 Matsuoka-Kenjojima, Eiheiji, Yoshida, Fukui, JAPAN
TEL
0776-61-6000
hibi@g.fpu.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Azuma |
Organization
Fukui Prefectural University
Division name
Faculty of Nursing & Social Welfare Sciences
Zip code
910-1195
Address
4-1-1 Matsuoka-Kenjojima, Eiheiji, Yoshida, Fukui, JAPAN
TEL
0776-61-6000
Homepage URL
azuma@g.fpu.ac.jp
Sponsor or person
Institute
Fukui Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukui Prefectural University
Address
4-1-1 Matsuoka-Kenjojima, Eiheiji, Yoshida, Fukui, JAPAN
Tel
0776-61-6000
hibi@g.fpu.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 | 08 | Month | 19 | 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 | 17 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 17 | 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 | 08 | Month | 18 | Day |
Last modified on
| 2026 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071490
