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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025809
Receipt No. 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

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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
Email 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
Email umemoto@ongene.med.osaka-u.ac.jp

Sponsor
Institute Laboratory of Immune Regulation, Department of Microbiology and Immunology, Osaka University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029248

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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