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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004441
Receipt No. R000005311
Scientific Title A prospective study of intestinal infection in relapse of inflammatory bowel disease
Date of disclosure of the study information 2010/10/25
Last modified on 2010/10/25

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Basic information
Public title A prospective study of intestinal infection in relapse of inflammatory bowel disease
Acronym A prospective study of intestinal infection in relapse of inflammatory bowel disease
Scientific Title A prospective study of intestinal infection in relapse of inflammatory bowel disease
Scientific Title:Acronym A prospective study of intestinal infection in relapse of inflammatory bowel disease
Region
Japan

Condition
Condition ulcerative colitis, Crohn's disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify the relation of intestinal infection in relapse of inflammatory bowel disease.
Basic objectives2 Others
Basic objectives -Others fact-finding
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The complication rate and cause of intestinal infection in relapse of inflammatory bowel disease.
Comparison of the disease activity index of 0, 2, 4, 8 week after starting protcol.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 blood examination
culture inspection
colonoscopy
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients of ulcerative colitis and Crohn's disease
Key exclusion criteria An infectious disease except the intestinal infection
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mika Omiya
Organization Kansai Medical University
Division name Third Department of Internal Medicine
Zip code
Address 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191, Japan
TEL 072-804-0101
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mika Omiya
Organization Kansai Medical University
Division name Third Department of Internal Medicine
Zip code
Address 2-3-1 Shinmachi, Hirakata, Osaka, 573-1191, Japan
TEL 072-804-0101
Homepage URL
Email omiyam@hirakata.kmu.ac.jp

Sponsor
Institute Third Department of Internal Medicine,Kansai Medical University
Institute
Department

Funding Source
Organization Health and Labour Science Research Grants from the Japanese Ministry of Health, Labour and Welfare, and Research on Measures for Intractable Disease (Inflammatory Bowel Disease)
Organization
Division
Category of Funding 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

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 25 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
2010 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 11 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

Management information
Registered date
2010 Year 10 Month 25 Day
Last modified on
2010 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005311

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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