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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024999
Receipt No. R000028753
Scientific Title A Pilot Study: Effect of probiotics supplementation on improving cognitive function
Date of disclosure of the study information 2016/11/29
Last modified on 2017/09/15

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Basic information
Public title A Pilot Study: Effect of probiotics supplementation on improving cognitive function
Acronym A Pilot Study of Probiotics
Scientific Title A Pilot Study: Effect of probiotics supplementation on improving cognitive function
Scientific Title:Acronym 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
1st name
Middle name
Last name Isao Saito
Organization Ehime University Graduate School of Medicine
Division name Department of Basic Nursing and Health Science
Zip code
Address 454 Shizukawa, Toon, Ehime
TEL 089-964-5111
Email saitoi@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsu Kinoshita
Organization Institute of Community Life Sciences Co., Ltd.
Division name Social Epidemiology Institute
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 29 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
2016 Year 11 Month 28 Day
Date of IRB
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

Other
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

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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