UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011711 |
|---|---|
| Receipt number | R000013669 |
| Scientific Title | Gut microbiota in stroke patients |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2016/03/16 13:22:21 |
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Basic information
Public title
Gut microbiota in stroke patients
Acronym
Gut microbiota in stroke patients
Scientific Title
Gut microbiota in stroke patients
Scientific Title:Acronym
Gut microbiota in stroke patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the characteristics of gut microbiota in stroke patients
Basic objectives2
Others
Basic objectives -Others
Pathophysiology
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The composition of gut microbiota
Key secondary outcomes
Bacteria and cytokines in the blood
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Acute stroke patients and age- and sex-matched outpatients with no cardiovascular health problems.
Key exclusion criteria
Patients with gastrostomy or stoma.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Yamashiro |
Organization
Juntendo University
Division name
Department of Neurology
Zip code
Address
Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL
03-3813-3111
kazuo-y@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Yamashiro |
Organization
Juntendo University
Division name
Department of Neurology
Zip code
Address
Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
kazuo-y@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | 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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 31 | Day |
Other
Other related information
Compositions of gut microbiota in stroke patients and control subjects
Management information
Registered date
| 2013 | Year | 09 | Month | 11 | Day |
Last modified on
| 2016 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013669
