UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060707 |
|---|---|
| Receipt number | R000069450 |
| Scientific Title | The effects of lactic acid bacteria ingestion on inflammation-related serum markers |
| Date of disclosure of the study information | 2026/02/26 |
| Last modified on | 2026/02/19 19:00:51 |
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Basic information
Public title
The effects of lactic acid bacteria ingestion on inflammation-related serum markers
Acronym
The effects of lactic acid bacteria ingestion on inflammation-related serum markers
Scientific Title
The effects of lactic acid bacteria ingestion on inflammation-related serum markers
Scientific Title:Acronym
The effects of lactic acid bacteria ingestion on inflammation-related serum markers
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess response in serum IL 10 levels following lactic acid bacteria ingestion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum IL-10 levels
Key secondary outcomes
Serum IL-6, IL-4, IGF-1 levels
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of lactic acid bacteria powder
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
| 30 | years-old | <= |
Age-upper limit
| 62 | years-old | > |
Gender
Male
Key inclusion criteria
1. Subjects who completed a previous study (UMIN000054363) and ingested a high dose of lactic acid bacteria powder
2. Subjects who provided written informed consent prior to participation
Key exclusion criteria
1. milk allergy
2. Subjects who donated 200 mL of blood within 1 month or 400 mL of blood within 3 months
3. Subjects deemed unsuitable for the study by the principal investigator for any other reason
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Chiaki |
| Middle name | |
| Last name | Sanbongi |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo
TEL
+81-42-632-5847
chiaki.sanbongi@meiji.com
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Yoshimura |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL
+81-42-632-5847
Homepage URL
aya.yoshimura.aa@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
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
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachioji, Tokyo, Japan
Tel
81-42-632-5900
MEIJI.IRB@meiji.com
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
医療法人社団 成守会成守会クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 26 | 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 | 01 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2026 | 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 | 02 | Month | 19 | Day |
Last modified on
| 2026 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069450
