UMIN-CTR Clinical Trial

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	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 23 Day
Date of IRB	2017 Year 09 Month 22 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
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	2020 Year 04 Month 01 Day

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