UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The observational study on the relations of small bowel endoscopic findings and variability of fecal markers in Crohn's disease
Title of the study (Brief title)	The observational study on the relations of small bowel endoscopic findings and fecal markers in Crohn's disease
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of endoscopic findings and variability of fecal calprotectin in Crohn's disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare fecal calprotectin with or without small-intestinal and colorectal lesion
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The patient aged 20 and more who planned double-ballon endoscopy for the suspected crohn's disease
Key exclusion criteria	1)Patients with acute abdomen 2)Patients with severe acute inflammation 3)pregnant patients 4)Patients in a very bad general condition 5)Patients having severe blood clotting defect 6)Patients who have participated in same clinical trials 7)Patients, the investigator (or the subinvestigator) considers, inappropriate for entry into the trial
Target sample size	50

Research contact person
Name of lead principal investigator	Watanabe Osamu
Organization	Nagoya University Hospital
Division name	Department of Gastroenterology and Hepatology
Address	65 Tsuruma-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL	052-744-2172
Email	osa-wata@med.nagoya-u.ac.jp

Public contact
Name of contact person	Masanao Nakamura
Organization	Nagoya University Hospital
Division name	Department of Gastroenterology and Hepatology
Address	65 Tsuruma-cho, Showa-ku, Nagoya, 466-8550, Japan
TEL	052-744-2172
Homepage URL
Email	makamura@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	Nagoya University Hospital
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	2015 Year 12 Month 04 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 12 Month 03 Day
Anticipated trial start date	2016 Year 01 Month 04 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	Measurements; Endoscopic findings/blood exam(red blood cells, white blood cells, hemogram, platelets, amylase, C-reactive protein, hepatobiliary system enzyme, lactase dehydrogenase, blood urea nitrogen, creatinine, total protein, albumin, erythrocyte sedimentation rate)/fecal calprotectin,immunological fecal occult blood test/IOIBD(International Organization for the Study of Inflammatory Bowel Disease)/CDAI(Crohn's Disease Activity Index)/histopathological findings

Management information
Registered date	2015 Year 12 Month 03 Day
Last modified on	2018 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023177