UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of lymphocyte composition of the intestine and peripheral blood in patients with inflammatory bowel disease
Acronym	Analysis of lymphocyte composition in inflammatory bowel disease patients
Scientific Title	Analysis of lymphocyte composition of the intestine and peripheral blood in patients with inflammatory bowel disease
Scientific Title:Acronym	Analysis of lymphocyte composition in inflammatory bowel disease patients
Region	Japan

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

Objectives
Narrative objectives1	To investigate lymphocyte composition of the intestine and peripheral blood in patients with inflammatory bowel disease
Basic objectives2	Others
Basic objectives -Others	To investigate and compare lymphocyte composition of the intestine and peripheral blood in patients with inflammatory bowel disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Differences of lymphocyte composition between the intestine and peripheral blood in patients with inflammatory bowel disease
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who are clinically diagnosed with inflammatory bowel disease and will undergo endoscopy, endoscopic biopsy, and blood test
Key exclusion criteria	none
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Masaya Middle name Last name Iwamuro
Organization	Okayama University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	0862357218
Email	iwamuromasaya@yahoo.co.jp

Public contact
Name of contact person	1st name Masaya Middle name Last name Iwamuro
Organization	Okayama University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	0862357218
Homepage URL
Email	iwamuromasaya@yahoo.co.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	Okayama University Hospital
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	Okayama University Hospital
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
Tel	0862357218
Email	iwamuromasaya@yahoo.co.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	2020 Year 03 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://journals.sagepub.com/doi/pdf/10.1177/20587384211051982
Number of participants that the trial has enrolled	13
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	2020 Year 01 Month 02 Day
Date of IRB	2020 Year 03 Month 06 Day
Anticipated trial start date	2020 Year 03 Month 18 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 03 Month 19 Day

Other
Other related information	none

Management information
Registered date	2020 Year 03 Month 18 Day
Last modified on	2022 Year 03 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045462