UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024999 |
|---|---|
| Receipt number | 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 13:15:22 |
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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
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
tetsu.prospective@gmail.com
Sponsor or person
Institute
Institute of Community Life Sciences Co., Ltd.
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028753
