UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of long-term intake of bifidobacterium on immunostimulatory action and intestinal regulation of younger women
Title of the study (Brief title)	Effect of long-term intake of bifidobacterium on immunostimulatory action and intestinal regulation of younger women
Region	Japan

Condition
Condition	Healthy individual
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine/verify the effect of long-term intake of bifidobacterium on immunostimulatory action and intestinal regulation
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Gastrointestinal flora
Key secondary outcomes	IgA

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Placebo control (without bifidobacteria) (Name of constituent) Potato starch, calcium stearate, and hydroxypropyl methylcellulose
Interventions/Control_2	Bifidobacterium supplement (with viable bifidobacteria) (Name of constituent) Viable bifidobacteria, potato starch, calcium stearate, and hydroxypropyl methylcellulose
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	Not applicable
Gender	Female
Key inclusion criteria	(1) The age at the time of obtaining a consent is 20 years or older. (2) Female (3) Those from whom a written consent can be obtained on a voluntary basis.
Key exclusion criteria	The person who is unsuitable for the entry judged by a officer.
Target sample size	30

Research contact person
Name of lead principal investigator	Motoko Takaoka
Organization	Kobe College
Division name	School of Human Sciences, Department of Biosphere Sciences
Address	4-1 Okadayama, Nhishinomiya-shi, Hyogo pref. 662-8506 Japan
TEL	0798-51-8668
Email	takaoka@mail.kobe-c.ac.jp

Public contact
Name of contact person	Takurou Ueki
Organization	Noevir Co., Ltd.
Division name	Groupwide Research and Development
Address	R&D C Building No. 333, Kanagawa Science park (KSP), 3-2-1 Sakado, Takatsu-ku, Kawasaki-shi, Kanagaw
TEL	044-813-2488
Homepage URL
Email	takurou_ueki@n1.noevir.co.jp

Sponsor
Institute	Kobe College
Institute
Department

Funding Source
Organization	Noevir Co., Ltd. DAC Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	神戸女学院大学（兵庫県） Kobe College（Hyogo Prefecture）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 03 Day
Anticipated trial start date	2017 Year 10 Month 16 Day
Last follow-up date	2017 Year 11 Month 30 Day
Date of closure to data entry	2017 Year 12 Month 14 Day
Date trial data considered complete	2018 Year 01 Month 31 Day
Date analysis concluded	2018 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 06 Day
Last modified on	2018 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033652