UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063546 |
|---|---|
| Receipt number | R000072716 |
| Scientific Title | The effect of yogurt intake on the antigen-binding affinity of salivary s-IgA and plasma IgG using existing samples collected in 2024 |
| Date of disclosure of the study information | 2026/11/06 |
| Last modified on | 2026/11/06 16:27:43 |
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Basic information
Public title
The effect of yogurt consumption on the antigen-binding affinity of salivary and plasma immunoglobulins using existing samples collected in 2024
Acronym
The effect of yogurt consumption on the antigen-binding affinity of salivary and plasma immunoglobulins using existing samples collected in 2024
Scientific Title
The effect of yogurt intake on the antigen-binding affinity of salivary s-IgA and plasma IgG using existing samples collected in 2024
Scientific Title:Acronym
The effect of yogurt intake on the antigen-binding affinity of salivary s-IgA and plasma IgG using existing samples collected in 2024
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of yogurt consumption on antigen-binding affinity of salivary and plasma immunoglobulins.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anti-influenza virus-reactive antibody levels and antigen-binding affinity of salivary and plasma immunoglobulins
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects of the other study (UMIN000056714)
Key exclusion criteria
1. Subjects who expressed their intention to withdraw from the study after the disclosure of information regarding its conduct.
2. Subjects from whom no saliva or plasma sample were obtained in the other study (UMIN000056714).
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kano |
Organization
Meiji Co., Ltd.
Division name
R&D division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji-shi, Tokyo 192-0919, Japan
TEL
+81-80-7841-6491
hiroshi.kano@meiji.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kano |
Organization
Meiji Co., Ltd.
Division name
R&D division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji-shi, Tokyo 192-0919, Japan
TEL
+81-80-7841-6491
Homepage URL
hiroshi.kano@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-shi, Tokyo 192-0919, 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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 06 | 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 | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is conducted using existing samples obtained in the previous study (UMIN000056714). No additional intervention or invasive procedure will be performed in this study.
Management information
Registered date
| 2026 | Year | 11 | Month | 06 | Day |
Last modified on
| 2026 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072716
