UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034315
Receipt number 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 17:56:25

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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 or person

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name



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

Value
https://center6.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