UMIN-CTR Clinical Trial

Basic information
Public title	Clinical survey to clarify the associations between cognitive function, activities of daily livings, and the gut microbiota
Acronym	Clinical survey to clarify the associations between cognitive function, activities of daily livings, and the gut microbiota
Scientific Title	Clinical survey to clarify the associations between cognitive function, activities of daily livings, and the gut microbiota
Scientific Title:Acronym	Clinical survey to clarify the associations between cognitive function, activities of daily livings, and 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	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Cognitive decline, functional status
Key secondary outcomes	Brain MRI findings, gut microbiota

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	1) Participants who visited 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 between 2016 and 2022. 2) Participants who were enrolled to the clinical research (MCHS-258) between 2003 and 2004 which had conducted at the Kyoto Prefectural University of Medicine.
Key exclusion criteria	Patient refusal or judged by an investigator to be ineligible to participate as a study subject.
Target sample size	700

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	Japan

Other related organizations
Co-sponsor	Kyoto Prefectural University of Medicine
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、京都府立医科大学

Other administrative information
Date of disclosure of the study information	2022 Year 09 Month 14 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	Preinitiation
Date of protocol fixation	2022 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date	2023 Year 01 Month 01 Day
Last follow-up date	2027 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-sectionally. The details will be mentioned in the article.

Management information
Registered date	2022 Year 09 Month 14 Day
Last modified on	2022 Year 09 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055748