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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034315
Receipt No. R000039122
Scientific Title Cognitive decline and impaired activities of daily livings caused by the gut microbiota
Date of disclosure of the study information 2018/10/01
Last modified on 2019/09/29

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Basic information
Public title Cognitive decline and impaired activities of daily livings caused by the gut microbiota
Acronym Cognitive decline and impaired activities of daily livings caused by the gut microbiota
Scientific Title Cognitive decline and impaired activities of daily livings caused by the gut microbiota
Scientific Title:Acronym Cognitive decline and impaired activities of daily livings caused by the gut microbiota
Region
Japan

Condition
Condition cognitive decline and cerebrovascular diseases
Classification by specialty
Medicine in general Neurology Geriatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify the association between cognitive function, activities of daily livings, and gut microbiota by means of analyzing gut microbiota and the various biomarkers
Basic objectives2 Others
Basic objectives -Others Assessment of gut microbiota and survey for biomarkers
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Cognitive decline, functional status, cardiovascular diseases
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who visit the memory clinic at the National Center for Geriatrics and Gerontology (NCGG) and agreed to both the medical check-up of cognitive function and the fecal examination to survey gut microbiota.Patients were eligible for the present study if they: (1) can undergo a brain magnetic resonance imaging (MRI); (2) have provided informed consent in writing; (3) are accompanied by a study partner to assess the patient's condition.
Key exclusion criteria Patients if they: (1) are unable to undergo MRI examination, or MRI cannot be evaluated due to body movement; (2) having any local lesion such as cerebral infarction(s) detected by MRI before enrollment that can greatly affect the cognitive function; (3) having a history of major psychological disorder, or alcohol/drug abuse as a current serious or unstable disease; (4) are having less than 6 years of education; (5) are having a history of digestive cancer; (6) are judged by an investigator to be ineligible to participate as a study subject.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Naoki
Middle name
Last name Saji
Organization National Center for Geriatrics and Gerontology
Division name Center for Comprehensive Care and Research on Memory Disorders
Zip code 474-8511
Address 7-430 Morioka, Obu, Aichi
TEL 0562-46-2311
Email sajink@nifty.com

Public contact
Name of contact person
1st name Naoki
Middle name
Last name Saji
Organization National Center for Geriatrics and Gerontology
Division name Center for Comprehensive Care and Research on Memory Disorders
Zip code 474-8511
Address 7-430 Morioka, Obu, Aichi
TEL 0562-46-2311
Homepage URL
Email sajink@nifty.com

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization Research grants from the Research Funding of Longevity Sciences from the National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center for Geriatrics and Gerontology
Address 7-430 Morioka, Obu, Aichi
Tel 0562-46-2311
Email sajink@nifty.com

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 国立長寿医療研究センター

Other administrative information
Date of disclosure of the study information
2018 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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
2018 Year 12 Month 05 Day
Anticipated trial start date
2018 Year 12 Month 05 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will analyze cross-sectionalaly and longitudinally, The details will be mentioned in the article.

Management information
Registered date
2018 Year 09 Month 28 Day
Last modified on
2019 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039122

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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