UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056576 |
|---|---|
| Receipt number | R000064657 |
| Scientific Title | Evaluation of the Effect of Apilactobacillus kunkeei YB38 Intake on the Activation of Peripheral Blood Plasmacytoid Dendritic Cells (pDC) |
| Date of disclosure of the study information | 2025/01/16 |
| Last modified on | 2024/12/26 11:16:10 |
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Basic information
Public title
Evaluation of the Effect of Apilactobacillus kunkeei YB38 Intake on the Activation of Peripheral Blood Plasmacytoid Dendritic Cells (pDC)
Acronym
Evaluation of the Effect of Apilactobacillus kunkeei YB38 Intake on the Activation of Peripheral Blood Plasmacytoid Dendritic Cells (pDC)
Scientific Title
Evaluation of the Effect of Apilactobacillus kunkeei YB38 Intake on the Activation of Peripheral Blood Plasmacytoid Dendritic Cells (pDC)
Scientific Title:Acronym
Evaluation of the Effect of Apilactobacillus kunkeei YB38 Intake on the Activation of Peripheral Blood Plasmacytoid Dendritic Cells (pDC)
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of consuming the lactic acid bacteria A.xyz (hereafter referred to as XYZ) for 12 weeks on immune function using peripheral blood pDC activation as an indicator in healthy adult men and women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pDC activity
Key secondary outcomes
IFN-alpha, mDC1/mDC2 activity
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
Functional food
Daily dosage: 1 cupsule/day
Duration: 84 days
Interventions/Control_2
Placebo food
Daily dosage: 1 cupsule/day
Duration: 84 days
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese men and women aged between 20 and 65 years at the time of consent.
2) Individuals who have been fully informed about the purpose and details of the study, have provided written consent, and voluntarily wish to participate.
3) Individuals deemed eligible by the principal investigator based on a comprehensive judgment
Key exclusion criteria
1) Individuals with a history of or current allergy to lactic acid bacteria.
2) Regular users of medications or supplements (including health-functional foods) that may affect the study results.
3) Individuals with a history of major gastrointestinal surgeries, such as gastrectomy, intestinal suture, or bowel resection.
4) Individuals with severe hepatic dysfunction, renal, cardiac, or organ disorders, diabetes, or other serious illnesses.
5 Individuals undergoing medication treatment for chronic diseases that may affect the study results or are expected to receive such treatment during the study period.
6) Individuals unable to maintain a regular lifestyle during the study period.
7) Individuals engaged in shift work.
8) Individuals who donated more than 200 mL of blood within 4 weeks or more than 400 mL of blood within 3 months prior to the start of the study.
9) Smokers (including electronic cigarettes).
10) Pregnant women or those planning to become pregnant.
11) Individuals who participated in another clinical study and received an intervention within the last 3 months.
12) Individuals deemed unsuitable for study participation by the principal investigator.
13) Regular users of medications such as phenytoin, antidepressants, analgesics, antihypertensives, antihistamines, or anti-Parkinsonian drugs.
14) Individuals planning to receive vaccines (influenza/COVID-19) during the study period or who received a vaccine within 6 months prior to the study's start.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takato |
| Middle name | |
| Last name | Nikaido |
Organization
Yamada Bee Company, Inc.
Division name
Functional research section, Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-1199
tn2381@yamada-bee.com
Public contact
Name of contact person
| 1st name | Akio |
| Middle name | |
| Last name | Ohkuma |
Organization
Research Center for Immunological Analysis, Inc.
Division name
-
Zip code
701-1221
Address
ORIC213, 5303, Haga, Kita-Ku, Okayama-shi, Okayama, Japan
TEL
086-286-9333
Homepage URL
info@menekibunseki.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Center for Immunological Analysis, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
shiba_palace@s-palace-clinic.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 16 | 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
| 2024 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 07 | 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
| 2024 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064657
