UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Establishment of a new diagnostic classification for UC patients using the intestinal flora pattern analysis
Title of the study (Brief title)	Establishment of a new diagnostic classification for UC patients using the intestinal flora pattern analysis
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate associations between various clinical classifications and fecal microbiota profiles in UC patients
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To identify characteristic fecal microbiota profiles in UC patients
Key secondary outcomes	The association between clinical characteristic (disease activity, disease duration, extent of colitis, clinical course etc.) and fecal microbiota profile The association between treatment responsiveness and fecal microbiota profile

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with ulcerative colitis
Key exclusion criteria	Patient who were judged to be exclusive by investigators
Target sample size	200

Research contact person
Name of lead principal investigator	Norihito Watanabe
Organization	Tokai University Hachioji Hospital
Division name	Division of Gastroenterology
Address	1838, Ishikawa-machi, Hachioji-shi, Tokyo
TEL	0426-39-1111
Email	norihito@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	Hitoshi Ichikawa
Organization	Tokai University Hachioji Hospital
Division name	Division of Gastroenterology
Address	1838, Ishikawa-machi, Hachioji-shi, Tokyo
TEL	0426-39-1111
Homepage URL
Email	ichikawa.hitoshi@plum.plala.or.jp

Sponsor
Institute	Tokai University Hachioji Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Saitama Medical University Hospital
Name of secondary funｄer(s)

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 03 Month 02 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 10 Month 07 Day
Anticipated trial start date	2014 Year 11 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The association between clinical characteristic (disease activity, disease duration, extent of colitis, clinical course etc.) and fecal microbiota profile The association between treatment responsiveness and fecal microbiota profile

Management information
Registered date	2015 Year 03 Month 01 Day
Last modified on	2016 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000019350