UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060317 |
|---|---|
| Receipt number | R000068405 |
| Scientific Title | Effect of continuous ingestion of yogurt fermented with OLL1073R-1 and OLS3059 strains on salivary IgA antibody secretion |
| Date of disclosure of the study information | 2026/01/10 |
| Last modified on | 2026/01/10 14:00:13 |
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Basic information
Public title
Effect of continuous ingestion of yogurt fermented with OLL1073R-1 and OLS3059 strains on salivary IgA antibody secretion
Acronym
Effects of yogurt intake on oral immune function
Scientific Title
Effect of continuous ingestion of yogurt fermented with OLL1073R-1 and OLS3059 strains on salivary IgA antibody secretion
Scientific Title:Acronym
Effects of yogurt intake on oral immune function
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is to obtain knowledge about the effect of ingestion of yogurt (Meiji Probio Yogurt R-1) fermented with Lactobacillus delbruekii subsp. bulgaricus OLL1073R-1 (hereinafter referred to as OLL1073R-1 strain) and Streptococcus thermophilus OLS3059 (hereinafter referred to as OLS3059 strain) on salivary s-IgA antibody secretion in young athletes. Moreover, a secondary objective of this study is to confirm the effects on body composition, body temperature, salivary cortisol concentration, and the health-related QOL scale (SF-8).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Salivary s-IgA antibody secretion level
Key secondary outcomes
Body composition, body temperature, salivary cortisol concentration, health-related quality of life scale (SF-8)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of yogurt (Meiji Probio Yogurt R-1) fermented with Lactobacillus delbruekii subsp. bulgaricus OLL1073R-1 (OLL1073R-1 strain) and Streptococcus thermophilus OLS3059 (OLS3059 strain) was performed daily at a dose of 112g/day for 8 weeks.
Interventions/Control_2
Eight weeks of normal living without yogurt.
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
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
Waseda University Rugby Football Club players
Key exclusion criteria
Those with dairy allergies, lactose intolerance, or Sjogren's syndrome
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Miyachi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
0429477313
miyachm@waseda.jp
Public contact
Name of contact person
| 1st name | Motohiko |
| Middle name | |
| Last name | Miyachi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
0429477313
Homepage URL
miyachim@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Motohiko Miyachi
Funding Source
Organization
others
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Secretariat of Ethics Review Committee on Research with Human Subjects
Address
1-104 Toyama-cho, Shinjuku, Tokyo 169-8050
Tel
0352721639
rinri@list.waseda.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
東京都
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 10 | 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 | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 23 | 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 | 01 | Month | 10 | Day |
Last modified on
| 2026 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068405
