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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011270
Receipt No. 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

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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
Email

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
Email takatomo@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013051

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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