UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058719 |
|---|---|
| Receipt number | R000067109 |
| Scientific Title | Effect of Different Intake Frequencies of Lactobacillus pentosus Strain B240 on Mucosal Immune Function |
| Date of disclosure of the study information | 2025/08/15 |
| Last modified on | 2025/08/07 04:05:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of Different Intake Frequencies of Lactobacillus pentosus Strain B240 on Mucosal Immune Function
Acronym
Effect of Different Intake Frequencies of Lactobacillus pentosus Strain B240 on Mucosal Immune Function
Scientific Title
Effect of Different Intake Frequencies of Lactobacillus pentosus Strain B240 on Mucosal Immune Function
Scientific Title:Acronym
Effect of Different Intake Frequencies of Lactobacillus pentosus Strain B240 on Mucosal Immune Function
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine changes in salivary immunoglobulin A (SIgA) levels and subjective health status when varying the intake frequency of Lactobacillus B240, in order to determine whether reducing the frequency of intake can still produce beneficial effects. By doing so, the study seeks to clarify the optimal intake method for athletes, thereby reducing both the financial burden and the burden of intake on the athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in salivary secretory immunoglobulin A (SIgA) concentration, secretion rate, and secretion volume, measured after acute high-intensity exercise before intake and during the Lactobacillus intake period (week 1, week 2, week 3, and week 4).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of one Lactobacillus pentosus strain B240 tablet per day (containing two times ten to the power of nine CFU of Lactobacillus B240) for 28 consecutive days.
Interventions/Control_2
Intake of one Lactobacillus pentosus strain B240 tablet (containing two times ten to the power of nine CFU of Lactobacillus B240) three days per week, and placebo tablets on the remaining four days, for 28 consecutive days.
Interventions/Control_3
Intake of one placebo tablet per day for 28 consecutive days.
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy male and female adults aged 18 to 30 years who agree to participate in this study and comply with the study protocol.
Key exclusion criteria
Members of university athletic clubs.
Individuals undergoing continuous medical treatment for any disease.
Individuals who will receive vaccinations during the study period.
Individuals for whom the principal investigator, who is a physician, deems it inappropriate to perform the exercise stress test.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Akama |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
579-15 Mikajima 2-chome, Tokorozawa-shi, Saitama, Japan
TEL
04-2947-6848
takao-akama@waseda.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Kobayashi |
Organization
Waseda University
Division name
Graduate School of Sport Sciences
Zip code
359-1192
Address
579-15 Mikajima 2-chome, Tokorozawa-shi, Saitama, Japan
TEL
04-2947-6848
Homepage URL
m.kobayashi@asagi.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Masayuki Kobayashi
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Secretariat, Ethics Review Committee on Research with Human Subjects, Waseda University
Address
1-104 Totsukamachi, Shinjuku-ku, Tokyo 169-8050, Japan
Tel
03-5272-1639
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 15 | 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
| 2025 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2025 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067109
