UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of fermented milk drink ingestion on human blood leukocyte subsets
Title of the study (Brief title)	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	Kiyoshi Takeda
Organization	Osaka University Graduate School of Medicine
Division name	Laboratory of Immune Regulation, Department of Microbiology and Immunology
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	Eiji Umemoto
Organization	Osaka University Graduate School of Medicine
Division name	Laboratory of Immune Regulation, Department of Microbiology and Immunology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029248