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
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
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
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
