UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031851 |
|---|---|
| Receipt number | R000029474 |
| Scientific Title | Cognitive decline and impaired activities of daily livings caused by the gut microbiota |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/09/22 11:02:28 |
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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
NO
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
100
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
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
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
Japanese Governmental office
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
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 | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-018-38218-7
Number of participants that the trial has enrolled
128
Results
The T-RFLP analysis revealed differences in the composition of the gut microbiome: the number of Bacteroides (enterotype I) was lower and the number of other bacteria (enterotype III) was higher in demented than non-demented patients. Multivariable analyses showed that the populations of enterotype I and enterotype III bacteria were strongly associated with dementia, independent of the traditional dementia biomarkers.
Results date posted
| 2020 | Year | 02 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 01 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analyzed cross-sectionalaly the data, The result was published as shown below.
Saji N. Relationship between the gut microbiome and dementia: a cross-sectional study conducted in Japan. Symposium: Nutrition and Cognition, Asian Congress of Nutrition 2019. August 7, 2019, Bali, Republic of Indonesia.
Saji N, Niida S, Murotani K, Hisada T, Tsuduki T, Sugimoto T, Kimura A, Toba K, Sakurai T. Analysis of the relationship between the gut microbiome and dementia: a cross-sectional study conducted in Japan. Sci Rep. 2019 Jan 30;9(1):1008. doi: 10.1038/s41598-018-38218-7.
Management information
Registered date
| 2018 | Year | 03 | Month | 23 | Day |
Last modified on
| 2020 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029474
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/02/01 | Protocol.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/02/01 | specification.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/02/01 | data.xlsx |
