UMIN-CTR Clinical Trial

Basic information
Public title	Coexistence of Allergic diseases and proinflammatory cytokine in inflammatory bowel disease(IBD) and irritable bowel syndrome(IBS)
Acronym	Coexistence of Allergic diseases and proinflammatory cytokine in IBD and IBS
Scientific Title	Coexistence of Allergic diseases and proinflammatory cytokine in inflammatory bowel disease(IBD) and irritable bowel syndrome(IBS)
Scientific Title:Acronym	Coexistence of Allergic diseases and proinflammatory cytokine in IBD and IBS
Region	Japan

Condition
Condition	Inflammatory bowel disease (IBD) ,irritable bowel syndrome (IBS) and healthy subjects
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify coexsistense of allergic diseases and proinflammatory cytokine profiles in IBS,IBD and healthy subjects
Basic objectives2	Others
Basic objectives -Others	To clarify coexsistense of allergic diseases and proinflammatory cytokine profiles in IBS,IBD and healthy subjects
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Coexsistense of allergic diseases and proinflammatory cytokine profiles in IBS,IBD and healthy subjects
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	Patients with inflammatory bowel disease and irritable bowel syndrome. And healthy subjects.
Key exclusion criteria	Nothing
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name Manabu Ishii
Organization	Kawasaki Medical School,
Division name	Gastroenterology Department of Internal Medicine
Zip code
Address	577, Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL	086-462-1111
Email	manabuisii@niji.or.jp

Public contact
Name of contact person	1st name Middle name Last name Manabu Ishii
Organization	Kawasaki Medical School
Division name	Gastroenterology Department of Internal Medicine
Zip code
Address	577, Matsushima, Kurashiki, Okayama 701-0192, Japan
TEL	086-462-1111
Homepage URL
Email	manabuisii@niji.or.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Kawasaki Medical School
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kouseikai Medical Corporation
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	2017 Year 02 Month 21 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	2017 Year 02 Month 21 Day
Date of IRB	2017 Year 03 Month 08 Day
Anticipated trial start date	2017 Year 03 Month 21 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Nothing

Management information
Registered date	2017 Year 02 Month 21 Day
Last modified on	2019 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029321