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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004123
Receipt No. R000004934
Scientific Title Analysis of intestinal flora by T-RFLP
Date of disclosure of the study information 2010/08/30
Last modified on 2015/04/10

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Basic information
Public title Analysis of intestinal flora by T-RFLP
Acronym Analysis of intestinal flora by T-RFLP
Scientific Title Analysis of intestinal flora by T-RFLP
Scientific Title:Acronym Analysis of intestinal flora by T-RFLP
Region
Japan

Condition
Condition Healthy
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analysis of intestinal flora in ulcerative colitis patients and the familiies.
Basic objectives2 Others
Basic objectives -Others Subject background
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analysis of intestinal flora
Key secondary outcomes Subject background

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 Ulcerative colitis patients and the families
Key exclusion criteria Nothing particular
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuyuyki Fukuda
Organization St. Luke's International Hospital
Division name Department of Gastroenterology
Zip code
Address 9-1, Akashi-cho, Chuo-ku Tokyo 104-8560 Japan
TEL 03-3541-5151
Email fukukats@luke.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyuki Fukuda
Organization St. Luke's International Hospital
Division name Department of Gastroenterology
Zip code
Address 9-1, Akashi-cho, Chuo-ku Tokyo 104-8560 Japan
TEL 03-3541-5151
Homepage URL
Email fukukats@luke.ac.jp

Sponsor
Institute St. Luke's International Hospital
Institute
Department

Funding Source
Organization Toa Pharmaceutical Company Limited
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
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 聖路加国際病院

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Determination of the Discriminant Score of Intestinal Microbiota as a Biomarker of Disease Activity in Patients with Ulcerative Colitis. Katsuyuki Fukuda and Yoshiyuki Fujita BMC Gastroenterology 2014, 14:49 (19 March 2014) 
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
2010 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analysis of intestinal flora by T-RFLP
Subject background

Management information
Registered date
2010 Year 08 Month 29 Day
Last modified on
2015 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004934

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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