UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006315 |
|---|---|
| Receipt number | R000004218 |
| Scientific Title | Classification and treatment effect forecast in inflammatory bowel disease patients by analysis of bacterium. |
| Date of disclosure of the study information | 2011/09/08 |
| Last modified on | 2014/09/10 02:52:58 |
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Basic information
Public title
Classification and treatment effect forecast in inflammatory bowel disease patients by analysis of bacterium.
Acronym
Analysis of Flore in intestines and colons of IBD patients
Scientific Title
Classification and treatment effect forecast in inflammatory bowel disease patients by analysis of bacterium.
Scientific Title:Acronym
Analysis of Flore in intestines and colons of IBD patients
Region
| Japan |
Condition
Condition
inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is a current state that the inflammatory bowel disease is an intractable disease of an uncertain cause, and doesn't have the treatment method still fixed. It is known that mice in germ-free condition don't develop and has been suggested that bacteria participate in colitis so far.
However, it was difficult for anarysis of bacteria in intestins. Then, it aims to analyze bacteria by a joint research covering it as the Yakult laboratory, and to establish a peculiar bacillus profile in inflammatory intestines disease patients.
Basic objectives2
Others
Basic objectives -Others
stool culture is gathered as well as usual. The treatment intervention is not done.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
before new treatment, 4 weeks and 8 weeks after treatment
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as UC or CD who take another new treatment
Key exclusion criteria
no
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanai Takanori |
Organization
Keio University school of medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
35 Shinanomachi Shinjyuku Tokyo
TEL
0334534521
tsujino@rockefeller.edu
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SujinoTomohisa |
Organization
Keio University school of medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
Shinanomachi35 Shinjyukuku
TEL
03-3353-1211
Homepage URL
tomosuji@yahoo.com
Sponsor or person
Institute
Keio University School of medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2011 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collect feases of patient diagnosed as IBD before and after treatment
Management information
Registered date
| 2011 | Year | 09 | Month | 08 | Day |
Last modified on
| 2014 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004218
