UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011270 |
|---|---|
| Receipt number | R000013051 |
| Scientific Title | The effectiveness of flu vaccine for the patients of inflammatory bowel disease |
| Date of disclosure of the study information | 2013/08/10 |
| Last modified on | 2013/07/25 00:05:59 |
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Basic information
Public title
The effectiveness of flu vaccine for the patients of inflammatory bowel disease
Acronym
The flu vaccine for the patients of inflammatory bowel disease
Scientific Title
The effectiveness of flu vaccine for the patients of inflammatory bowel disease
Scientific Title:Acronym
The flu vaccine for the patients of inflammatory bowel disease
Region
| Japan |
Condition
Condition
inflammatory bowel disease
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of flu vaccine for the patients of inflammatory bowel disease who received immunomodulator or anti TNF-alpha antibody.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The flu antibody (type A or B) concentration before and 4 weeks after flu vaccination
Key secondary outcomes
The disease ratio of flu during observation period and adverse events by flu vaccine
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of ulcerative colitis or Crohn's disease who have been treated with immunomodulator or anti TNF-alpha antibody for at least 3 months are registered.
Key exclusion criteria
Patients who are decided to unsuitable person by attending doctor.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohisa Takagi |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
Homepage URL
takatomo@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 08 | Month | 10 | 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
Completed
Date of protocol fixation
| 2012 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
The random sampling, 1 arm, and prospective observational study.
Management information
Registered date
| 2013 | Year | 07 | Month | 25 | Day |
Last modified on
| 2013 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013051
