UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031679 |
|---|---|
| Receipt number | R000036183 |
| Scientific Title | Effect of Probiotic Intake on Improvement of Higher Cerebral Function in Participants with Suspected Mild Cognitive Impairment |
| Date of disclosure of the study information | 2018/04/04 |
| Last modified on | 2018/10/29 12:34:30 |
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Basic information
Public title
Effect of Probiotic Intake on Improvement of Higher Cerebral Function in Participants with Suspected Mild Cognitive Impairment
Acronym
Effect of Probiotic on Participants with Suspected Mild Cognitive Impairment
Scientific Title
Effect of Probiotic Intake on Improvement of Higher Cerebral Function in Participants with Suspected Mild Cognitive Impairment
Scientific Title:Acronym
Effect of Probiotic on Participants with Suspected Mild Cognitive Impairment
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effect of probiotics supplementation for 12 weeks on brain function in participants who are concerned about forgetfulness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
RBANS
MMSE
Key secondary outcomes
POMS2(Short Form)
Patient Health Questionnaire-9 (PHQ-9)
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
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
12-week intake of the test food
Interventions/Control_2
12-week intake of the placebo food
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age:50 and over, below 80.
2) Sex:Males and females with Japanese nationality.
3) Subjects whose MMSE score is 22 to 27.
Key exclusion criteria
1) Subjects who are under medication or treatment for serious disease.
2) Subjects who are under diet therapy and exercise therapy in the control of doctor.
3) Subjects with a history of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological and metabolic diseases or those who undertake medication or treatment for such disease.
4) Subjects having a history of major surgery involving gastrectomy, gastrointestinal suture surgery, bowel resection, digestive system etc. (except fo rappendicitis)
5) Subjects with a current or past history of psychiatric disorders.
6) Subjects with a current or past history of drug or food allergy.
7) Subjects who are diagnosed as dementia.
8) Subjects who are receiving or have a history of drug dependence or drug abuse.
9) Subjects who have participated in other clinical tests within the past one months.
10) Subjects with irregular working hours, such as night shifts.
11) Subjects with a current or past history of alcoholism.
12) 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 | Matsuoka Masao |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
OekkusuBldg.10F, 5-31-19 Shiba Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
matsuoka@huma-c.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Matsuoka Masao |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
Address
Oekkusu Bldg.10F, 5-31-19 Shiba Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
matsuoka@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industy Co, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2018 | Year | 04 | Month | 04 | 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
| 2018 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 27 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 10 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 10 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 12 | Day |
Last modified on
| 2018 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036183
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| Registered date | File name |
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| Registered date | File name |
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