UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the Prevalence of celiac disease in Japan.
Title of the study (Brief title)	Prevalence of celiac disease.
Region	Japan

Condition
Condition	Celiac disease.
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to reveal the prevalence of celiac disease in healthy people who have a complete medical check-up.
Basic objectives2	Others
Basic objectives -Others	to reveal the prevalence of celiac disease in patients who have functional chronic abdominal symptoms.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	anti-tissue transglutaminase IgA antibody. serum endomysial IgA antibody (EMA).
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	Healthy people who visit medical check-up Patients who complained of abdominal discomfort, as abdominal pain, diarrhea and constipation, with negative endoscopy/radiology test and laboratory data were enrolled.
Key exclusion criteria	nothing
Target sample size	2300

Research contact person
Name of lead principal investigator	Yoshikazu Kinoshita
Organization	Shimane University School of Medicine
Division name	department of Gastroenterology and Hepatology
Address	89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL	0853202190
Email	imaganasu@yahoo.co.jp

Public contact
Name of contact person	Yoshikazu Kinoshita
Organization	Shimane University School of Medicine
Division name	department of Gastroenterology and Hepatology
Address	89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL	0853-20-2190
Homepage URL
Email	imaganasu@yahoo.co.jp

Sponsor
Institute	Shimane University School of Medicine
Institute
Department

Funding Source
Organization	Shimane University School of Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
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	島根大学医学部付属病院（島根県）、島根県環境保険公社総合健診センター（島根県） 松江赤十字病院（島根県）、松江市立病院（島根県）、島根県立中央病院（島根県） 出雲市総合医療センター（島根県）、益田地域医療センター医師会病院（島根県）

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 04 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	prospective study

Management information
Registered date	2014 Year 03 Month 31 Day
Last modified on	2018 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015846