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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029340
Receipt No. R000033515
Scientific Title Effect of probiotics supplementation on improving cognitive function Mild cognitive impairment (MCI)
Date of disclosure of the study information 2017/10/01
Last modified on 2017/09/28

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Basic information
Public title Effect of probiotics supplementation on improving cognitive function Mild cognitive impairment (MCI)
Acronym probiotics and MCI
Scientific Title Effect of probiotics supplementation on improving cognitive function Mild cognitive impairment (MCI)
Scientific Title:Acronym probiotics and MCI
Region
Japan

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

Objectives
Narrative objectives1 To explore the effect of probiotics supplementation on cognitive function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes TDAS(Touch Panel Type Dementia Assessment Scale), Digit Symbol substitution Test
Key secondary outcomes

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 Institution is considered as a block.
Blocking YES
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of 2 sachets containing probiotics per day for 24 weeks
Interventions/Control_2 Intake of 2 placebo sachets per day for 24 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
65 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria (1) Subjects whose TDAS score is 7 to 13.
(2) Those who can understand the purpose and the contents of this study, and can agree with participation.
Key exclusion criteria (1) subjects who are diagnosed as dementia
(2) subjects who are stroke patient or have medical history of stroke.
(3) subjects who are apnea syndrome patient or have medical history of apnea syndrome.
(4) subjects who regularly use medicine or supplement which affect gut-microbiota.
(5) subjects with severe disease or medical history of severe disease.
(6) Subjects who have participated in other clinical tests within the past three months
(7)Subjects who were judged inadequate by investigator for other reasons
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taeko Shimoda
Organization Nara Women's University Faculty of human life and environment
Division name Department of food science and nutrition
Zip code
Address kitauoyanishimachi, Nara, Nara
TEL 0742-20-3893
Email t-shimoda@cc.nara-wu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taeko Shimoda
Organization Nara Women's University Faculty of human life and environment
Division name Department of food science and nutrition
Zip code
Address kitauoyanishimachi, Nara, Nara
TEL 0742-20-3893
Homepage URL
Email t-shimoda@cc.nara-wu.ac.jp

Sponsor
Institute Nara Women's University
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
2017 Year 10 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 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
2017 Year 09 Month 28 Day
Last modified on
2017 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033515

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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