UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to investigate the effects of Bifidobacteria on stress relief: a randomized, double-blind, placebo-controlled, parallel-group comparative study.
Title of the study (Brief title)	Effects of Bifidobacteria on stress relief.
Region	Japan

Condition
Condition	None
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of intake of Bifidobacteria on stress relief.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual analog scale questionnaire
Key secondary outcomes	Saliva stress marker, POMS, Autonomic nervous activity.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of supplement containing Bifidobacteria for 8 weeks.
Interventions/Control_2	Ingestion of placebo for 8 weeks.
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	18 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy men and women aged more than 18 years, less than 65 years.
Key exclusion criteria	1)Subject who is under medication for chronic disease. 2)Subject with hepatic disease, renal dysfunction, cardiovascular disorder, gastrointestinal disorder, respiratory dysfunction, blood disease, autoimmune disease, endocrine disease, metabolic disease and these severe medical history. 3)Subject with serious allergy to specific medicine or food. 4)Subject who is pregnant or under lactation, or who is expected to be pregnant during the study. 5)Subject who constantly take medicines and/or supplements affecting gut microbiota. 6)Heavy drinker. 7)Subject who is ineligible due to physician's judgment.
Target sample size	120

Research contact person
Name of lead principal investigator	Keiko Sugiura
Organization	Matsumoto Junior College
Division name	Department of Nursing
Address	3118, Sasaga, Matsumoto, Nagano, Japan
TEL	0263-58-4417
Email	mjc-k.sugiura@matsutan.ac.jp

Public contact
Name of contact person	Terumi Yamashita
Organization	Matsumoto Junior College
Division name	Department of Nursing
Address	3118, Sasaga, Matsumoto, Nagano, Japan
TEL	0263-58-4417
Homepage URL
Email	mjc-t.yamasita@matsutan.ac.jp

Sponsor
Institute	Matsumoto Junior College
Institute
Department

Funding Source
Organization	Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Matsumoto Health Lab
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

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 10 Day
Anticipated trial start date	2017 Year 08 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 08 Month 31 Day
Last modified on	2018 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033039