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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006315
Receipt No. 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

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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
Email 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
Email tomosuji@yahoo.com

Sponsor
Institute Keio University School of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004218

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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