UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004441 |
|---|---|
| Receipt number | 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 | 2021/11/02 15:20:34 |
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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 | Mika |
| Middle name | |
| Last name | Mika |
Organization
Kansai Medical University
Division name
Third Department of Internal Medicine
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata, Osaka, 573-1191, Japan
TEL
072-804-0101
omiyam@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Omiya |
Organization
Kansai Medical University
Division name
Third Department of Internal Medicine
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata, Osaka, 573-1191, Japan
TEL
072-804-0101
Homepage URL
omiyam@hirakata.kmu.ac.jp
Sponsor or person
Institute
Third Department of Internal Medicine,Kansai Medical University
Institute
Department
Personal name
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
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
2-3-1 Shinnmachi Hirakata Osaka
Tel
072-804-0101
omiyam@hirakata.kmu.ac.jp
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
Terminated
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
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
| 2021 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005311
