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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031679
Receipt No. 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

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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
Email 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
Email matsuoka@huma-c.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036183

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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