UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation on EBV infection status and immunosuppressive treatment in Japanese IBD patients
Title of the study (Brief title)	EBISU study
Region	Japan

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

Objectives
Narrative objectives1	In this study, we investigate the EBV antibody titer of patients with IBD including children and clarify the prevalence of EBV infection by age. Then, it compares with the use situation of IBD therapeutic agent, especially thiopurine preparation and biological preparation, and clarifies the actual situation in Japan.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of EBV infection by age in patient with 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	Patient with IBD of all age.
Key exclusion criteria	Patient who can not obtain consent of participation in this study.
Target sample size	510

Research contact person
Name of lead principal investigator	Tadakazu Hisamatsu
Organization	Kyorin University School of Medicine
Division name	The Third Department of Internal Medicine
Address	6-20-2 Shinkawa Mitaka Tokyo
TEL	0422-47-5511
Email	thisamatsu@ks.kyorin-u.ac.jp

Public contact
Name of contact person	Miki Miura
Organization	Kyorin University School of Medicine
Division name	The Third Department of Internal Medicine
Address	6-20-2 Shinkawa Mitaka Tokyo
TEL	0422-47-5511
Homepage URL
Email	jasmine.miu.m@gmail.com

Sponsor
Institute	Kyorin University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 07 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 02 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	As a cross sectional observational study, we will clarify the status of EBV infection by age.

Management information
Registered date	2018 Year 06 Month 15 Day
Last modified on	2018 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036752