UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029340
Receipt number 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 2020/04/01 18:41:21

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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 or person

Institute

Nara Women's University

Institute

Department

Personal name



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

Value
https://center6.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