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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014602
Receipt No. R000016992
Scientific Title Multicenter observational study for disease course and therapeutic outcomes in inflammatory bowel disease
Date of disclosure of the study information 2014/07/21
Last modified on 2017/08/07

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Basic information
Public title Multicenter observational study for disease course and therapeutic outcomes in inflammatory bowel disease
Acronym Multicenter observational study for disease course and therapeutic outcomes in IBD
Scientific Title Multicenter observational study for disease course and therapeutic outcomes in inflammatory bowel disease
Scientific Title:Acronym Multicenter observational study for disease course and therapeutic outcomes in IBD
Region
Japan

Condition
Condition inflammatory bowel disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the factors influencing therapeutic outcomes and disease course of IBD by investigating lifestyle and disease seasonality.
Basic objectives2 Others
Basic objectives -Others Observational study using questionnaire
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To analyze disease seasonality and mental state for disease onset and exacerbation in IBD.
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria IBD patients (Crohn's disease, ulcerative colitis, and intestinal Behcet disease) who are regularly visiting at Osaka University hospital and related institutions.
Key exclusion criteria Patients who are not suitable for attending the study
Target sample size 1000

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tetsuo Takehara
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-2 K1, Yamadaoka, Suita, Osaka
TEL 06-6879-3621
Email takehara@gh.med.osaka-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shinichiro Shinzaki
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-2 K1, Yamadaoka, Suita, Osaka
TEL 06-6879-3621
Homepage URL http://www.med.osaka-u.ac.jp/pub/gh/research_jisyu.html
Email shinzaki@gh.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2014 Year 07 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2013 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2013 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 Retrospective analysis is performed by collecting information including lifestyle and disease seasonality. Prospective analysis will be performed using regularly collected information such as therapeutic outcomes and disease courses.

Management information
Registered date
2014 Year 07 Month 21 Day
Last modified on
2017 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016992

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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