UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of celiac disease antibodies and IgG4 antibody in inflammatory bowel disease
Title of the study (Brief title)	Study of celiac disease antibodies and IgG4 antibody in IBD
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 reveal clinical usefulness of celiac anntibodies and IgG4 antibody in inflammatory bowel disease
Basic objectives2	Others
Basic objectives -Others	to reveal clinical usefulness of celiac anntibodies and IgG4 antibody in IBD
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	anti-gliadin IgG, anti-gliadin IgA,anti-tissue transglutaminase IgG,anti-tissue transglutaminase IgA,anti-deamidated gliadin peptide IgA,anti-deamidated gliadin peptide IgG,IgG4 antibody
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
Key exclusion criteria	nothing
Target sample size	300

Research contact person
Name of lead principal investigator	Manabu Ishii
Organization	Kawasaki Medical School
Division name	Gastroenterology Department of Internal Medicine
Address	577, Matsushima, Kurashiki city
TEL	086-462-1111
Email	manabuisii@niji.or.jp

Public contact
Name of contact person	Manabu Ishii
Organization	Kawasaki Medical School
Division name	Gastroenterology Department of Internal Medicine
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
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	2016 Year 06 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 03 Month 09 Day
Anticipated trial start date	2016 Year 06 Month 10 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	None

Management information
Registered date	2016 Year 06 Month 09 Day
Last modified on	2018 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024686