UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Pilot Study: Effect of probiotics supplementation on improving cognitive function
Title of the study (Brief title)	A Pilot Study of Probiotics
Region	Japan

Condition
Condition	MCI (Mild Cognitive Impairment)
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The evaluation of effect of probiotics supplementation on dementia prevention
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mini Mental State Examination
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of probiotics supplement for 24 weeks
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Male and female of MCI (Mild Cognitive Impair) (2) Those who can understand the purpose and the contents of this study, and can agree with participation by letter.
Key exclusion criteria	(1)Subjects who show allergic responses to dairy products (2) Subjects who have participated in other clinical tests within the past three months (3)Subjects who were judged inadequate by investigator for other reasons
Target sample size	40

Research contact person
Name of lead principal investigator	Isao Saito
Organization	Ehime University Graduate School of Medicine
Division name	Department of Basic Nursing and Health Science
Address	454 Shizukawa, Toon, Ehime
TEL	089-964-5111
Email	saitoi@m.ehime-u.ac.jp

Public contact
Name of contact person	Tetsu Kinoshita
Organization	Institute of Community Life Sciences Co., Ltd.
Division name	Social Epidemiology Institute
Address	1383-2 hiraimachi, Matsuyama, Ehime
TEL	089-904-7811
Homepage URL
Email	tetsu.prospective@gmail.com

Sponsor
Institute	Institute of Community Life Sciences Co., Ltd.
Institute
Department

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

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 28 Day
Anticipated trial start date	2016 Year 11 Month 29 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	2016 Year 11 Month 25 Day
Last modified on	2017 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028753