UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054577 |
|---|---|
| Receipt number | R000061999 |
| Scientific Title | A verification study on the effects of a beverage containing the probiotic Lactococcus 11/19-B1 on nasal mucociliary clearance function and immune activation: a randomized, double-blind, placebo-controlled, parallel-group study. |
| Date of disclosure of the study information | 2024/06/05 |
| Last modified on | 2025/12/02 17:14:07 |
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Basic information
Public title
A verification study on the effects of a beverage containing the probiotic Lactococcus 11/19-B1 on nasal mucociliary clearance function and immune activation.
Acronym
A verification study on the effects of Lactococcus 11/19-B1 on nasal mucociliary clearance function and immune activation.
Scientific Title
A verification study on the effects of a beverage containing the probiotic Lactococcus 11/19-B1 on nasal mucociliary clearance function and immune activation: a randomized, double-blind, placebo-controlled, parallel-group study.
Scientific Title:Acronym
A verification study on the effects of Lactococcus 11/19-B1 on nasal mucociliary clearance function and immune activation: a randomized, double-blind, placebo-controlled, parallel-group study.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of continuous intake of Lactococcus 11/19-B1 on nasal mucociliary clearance function and immune activation in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nasal mucociliary clearance time(saccharin tests)
Key secondary outcomes
Blood natural killer (NK) cell activity, blood cytokine levels, blood biochemical parameters, self-reported throat discomfort (irritating, dry throat)
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
The volunteers are treated for four weeks with a 100 mL drink containing Lactococcus 11/19-B1 (10 billion bacterial cells/100 mL) once daily.
Interventions/Control_2
The volunteers are treated for four weeks with a 100 mL drink without Lactococcus 11/19-B1 once daily.
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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The individuals who are considered as appropriate for the study by the physician.
2. Within 1, those with low mucociliary clearance function in the nasal are preferentially selected.
Key exclusion criteria
1. Subjects who have a current or past history of serious illness.
2. Subjects who regularly consume commercially available drugs, quasi-drugs, supplements, foods for specified health uses, and foods with functional claims.
3. Subjects with a current or past history of drug or food allergies.
4. Subjects who have donated component blood or 200 mL of whole blood within one month of the start of this study.
5. Subjects who have donated 400 mL of whole blood within 4 months of the start of this study.
6. Subjects who have participated in or are currently participating in other clinical trials or research within one month before obtaining consent or those who plan to participate during the study period.
7. Subjects who are currently pregnant or breastfeeding or those who wish to become pregnant during the study period.
8. Subjects who drink a lot of alcohol daily (60g/day in terms of alcohol).
9. Subjects with irregular lifestyles, such as those with extremely irregular eating habits, those who work shifts, or those who work late at night.
10. Subjects judged by the study director to be unsuitable for participation in this study.
11. Subjects with a smoking habit within the past 2 years.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Atsuo |
| Middle name | |
| Last name | Nakamura |
Organization
Kyodo Milk Industry Co., Ltd.
Division name
Research Laboratories
Zip code
1900182
Address
20-1 Hirai, Hinode-machi, Nishitama-gun, Tokyo
TEL
0425975965
a-nakamura@meito.co.jp
Public contact
Name of contact person
| 1st name | Tsuoyoshi |
| Middle name | |
| Last name | Takahama |
Organization
Seishukai Clinic
Division name
Clinical trial office
Zip code
111-0036
Address
3-18-5 Matsugaya, Taito-ku, Tokyo
TEL
080-4410-9269
Homepage URL
t-takahama@seishukai.or.jp
Sponsor or person
Institute
Kyodo Milk Industry Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyodo Milk Industry 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
Seishukai clinic
Address
3-18-5 Matsugaya, Taito-ku, Tokyo
Tel
080-4410-9269
t-takahama@seishukai.or.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
| 2024 | Year | 06 | Month | 05 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 02 | Day |
Date trial data considered complete
| 2024 | Year | 11 | Month | 08 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061999
