UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028303 |
|---|---|
| Receipt number | R000032400 |
| Scientific Title | Exploratory research about correlation between mental disorder and gut microbiota and inter-organ communication |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2023/07/27 16:57:41 |
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Basic information
Public title
Exploratory research about correlation between mental disorder and gut microbiota and inter-organ communication
Acronym
Mental disorders and gut microbiota
Scientific Title
Exploratory research about correlation between mental disorder and gut microbiota and inter-organ communication
Scientific Title:Acronym
Mental disorders and gut microbiota
Region
| Japan |
Condition
Condition
mental disorders
Classification by specialty
| Gastroenterology | Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This research aims to assess relationship exploratorily, between mental disorders and gut microbiota, metabolic product and transcriptional product.
Basic objectives2
Others
Basic objectives -Others
pathological study
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the relationship between gut microbiota and psychiatric diagnosis, sub-diagnosis, symptoms and cognitive function
Key secondary outcomes
1. To identify disease-specific bacteria
2. To assess dysbiosis
3. To establish explanatory model of disease, with using predictive functional profiling of microbial communities
4. metabolome and proteome analaysis
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
Case group; patients suffering with multi-factorial mental disorders.
Control group; healthy adult candidates.
Key exclusion criteria
underage, people without a capacity for judgment, unconscious and people needed to be carefully informed with disease name.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Ozaki |
Organization
Nagoya University Graduate School of Medicine
Division name
Psychiatry
Zip code
466-8550
Address
Tsurumaicho 65, Showa-ku, Nagoya City
TEL
+81527442282
ozaki-n@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Imaeda |
Organization
Nagoya University Hospital
Division name
Psychiatry
Zip code
4668550
Address
Tsurumaicho 65, Showa-ku, Nagoya City
TEL
0527442282
Homepage URL
imaeda-m@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The KAITEKI Institute, Inc
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
Bioethics Committee of Nagoya University Hospital
Address
Tsurumaicho 65, Showa-ku, Nagoya City
Tel
0527412111
ethics@med.nagoya-u.ac.jp
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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Gut microbiota, metabolic products and transcript products will be analysed. The relationship between them and clinical information, the difference between case and control will be assessed.
Management information
Registered date
| 2017 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032400
