UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018937 |
|---|---|
| Receipt number | R000021913 |
| Scientific Title | An association study of intestinal bacteria with peripheral Th cell responses |
| Date of disclosure of the study information | 2015/09/08 |
| Last modified on | 2020/03/12 09:17:17 |
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Basic information
Public title
An association study of intestinal bacteria with peripheral Th cell responses
Acronym
An association study of gut metagenomics
and Th cell responses
Scientific Title
An association study of intestinal bacteria with peripheral Th cell responses
Scientific Title:Acronym
An association study of gut metagenomics
and Th cell responses
Region
| Japan |
Condition
Condition
Rheumatoid arthritis, Behcet's disease, SLE
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We hypothesize that changed composition and function of gut bacteria activate T cells and are related to the disease aggravation. We compare metagenomics data with T cell responces.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To develop a new analysis of the pathogenesis of autoimmune 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients fulfilled the diagnostic criteria proposed by ACR/EULAR. (Rheumatoid arthritis)
Patients fulfilled the diagnostic criteria proposed by the International Study Group. (Behcet's Disease)
Patients fulfilled the diagnostic criteria proposed by ACR. (SLE)
Key exclusion criteria
None
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Shimizu |
Organization
St. Marianna University School of Medicine
Division name
Department of Immunology and Medicine
Zip code
216-8511
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Japan
TEL
044-977-8111
jshimizu@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Shimizu |
Organization
St. Marianna University School of Medicine
Division name
Department of Immunology and Medicine
Zip code
216-8511
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Japan
TEL
044-977-8111
Homepage URL
jshimizu@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MEXT (Japan)
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
St. Marianna University School of Medicine
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki-shi, 216-8511, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2035 | 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 the data of 12 patients and 12 normal individuals. We submitted the data now.
Management information
Registered date
| 2015 | Year | 09 | Month | 08 | Day |
Last modified on
| 2020 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021913
