UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053525 |
|---|---|
| Receipt number | R000061087 |
| Scientific Title | Study to Determine the Effects of Fermented Milk Drink on activated CD4+ T cells in Peripheral Blood Mononuclear Cells. |
| Date of disclosure of the study information | 2024/02/06 |
| Last modified on | 2024/08/05 11:14:09 |
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Basic information
Public title
Study to Determine the Effects of Fermented Milk Drink on activated CD4+ T cells in Peripheral Blood Mononuclear Cells.
Acronym
Study to Determine the Effects of Fermented Milk Drink on activated CD4+ T cells in Peripheral Blood Mononuclear Cells.
Scientific Title
Study to Determine the Effects of Fermented Milk Drink on activated CD4+ T cells in Peripheral Blood Mononuclear Cells.
Scientific Title:Acronym
Study to Determine the Effects of Fermented Milk Drink on activated CD4+ T cells in Peripheral Blood Mononuclear Cells.
Region
| Japan |
Condition
Condition
Male/Female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of immunity index of peripheral blood CD4+ T cells by the intake of a fermented milk drink containing lactic acid bacteria.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expression of activation markers on activated CD4+ T cells
Key secondary outcomes
1. Immune cell composition of Peripheral Blood Mononuclear Cells.
2. Immune-related markers in plasma.
3. Immune-related markers in feces.
4. Metabolites in feces.
5. Background questionnaire on daily life
6. Daily questionnaire on test drink and health condition.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of a fermented milk drink (1 bottle a day) for 8 weeks.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Males and females aged 20 to below 60 years at the time of consent acquisition.
2. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who experience abdominal symptoms (such as diarrhea, abdominal pain, bloating) upon consumption of dairy products.
2. Subjects who regularly use Food for Specified Health Uses (FOSHU), Foods with Function Claims, or health food (including supplements) more than twice a week, which may potentially affect the study and cannot discontinue them from the time of consent acquisition.
3. Subjects who are taking medications (such as antibiotics, Intestinal preparations, laxatives) more than twice a week, which may potentially affect the trial, and cannot restrict their use during the study period.
4. Subjects who excessive alcohol intake.
5. Subjects who smoke heavily (not less than 21 cigarettes a day)
6. Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Naito |
Organization
Yakult Honsha Co., Ltd.
Division name
Yakult Central Institute
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi, Tokyo, Japan
TEL
042-577-8920
tomoaki-naito@yakult.co.jp
Public contact
Name of contact person
| 1st name | Tomoaki |
| Middle name | |
| Last name | Naito |
Organization
Yakult Honsha Co., Ltd.
Division name
Yakult Central Institute
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi, Tokyo, Japan
TEL
042-577-8920
Homepage URL
tomoaki-naito@yakult.co.jp
Sponsor or person
Institute
Yakult Honsha Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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, 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
| 2024 | Year | 02 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 02 | Day |
Last modified on
| 2024 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061087
