UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025809 |
|---|---|
| Receipt number | R000029248 |
| Scientific Title | Effects of fermented milk drink ingestion on human blood leukocyte subsets |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2018/01/24 10:44:36 |
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Basic information
Public title
Effects of fermented milk drink ingestion on human blood leukocyte subsets
Acronym
Effects of fermented milk drink ingestion on human blood leukocytes
Scientific Title
Effects of fermented milk drink ingestion on human blood leukocyte subsets
Scientific Title:Acronym
Effects of fermented milk drink ingestion on human blood leukocytes
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been reported that disruption of gut microbiota composition (dysbiosis) is associated with pathogenesis of various diseases. Recently beneficial bacteria (probiotics) are focused on improving health, although how they affect immune cells is not fully understood. In this study, we aim to investigate whether ingestion of fermented milk drink for months affects leukocyte populations in peripheral blood in healthy human subjects.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The cell number and proportion of leukocyte subsets in the peripheral blood
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The group provided with fermented milk drink. They will take a bottle of drink (Yakult; containing Lactobacillus casei Shirota 2 x 10^10) per day for three months.
Interventions/Control_2
The group not provided with fermented milk drink.
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
| 16 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subjects recruited from high school students with age 16-18 years
Key exclusion criteria
The following subjects will be excluded;
-taking antibiotics within previous two months.
-showing any infectious symptoms within previous two months.
-currently contracting any chronic diseases.
-taking any dietary supplements on a daily basis.
-taking yogurt more than 3 times per week.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Takeda |
Organization
Osaka University Graduate School of Medicine
Division name
Laboratory of Immune Regulation, Department of Microbiology and Immunology
Zip code
Address
2-2 Yamada-oka, Suita, Osaka
TEL
06-6879-3982
ktakeda@ongene.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Umemoto |
Organization
Osaka University Graduate School of Medicine
Division name
Laboratory of Immune Regulation, Department of Microbiology and Immunology
Zip code
Address
2-2 Yamada-oka, Suita, Osaka
TEL
06-6879-3982
Homepage URL
umemoto@ongene.med.osaka-u.ac.jp
Sponsor or person
Institute
Laboratory of Immune Regulation, Department of Microbiology and Immunology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Laboratory of Immune Regulation, Department of Microbiology and Immunology, Osaka University Graduate School of Medicine
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
Address
Tel
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
大阪大学医学系研究科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 23 | Day |
Last modified on
| 2018 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029248
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
