UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the relationship between fecal marker (calprotectin, lactoferrin) and magnifying endoscopic stratification in patients with ulcerative colitis in clinical remission
Title of the study (Brief title)	Study on the relationship between fecal marker (calprotectin, lactoferrin) and magnifying endoscopic stratification in patients with ulcerative colitis in clinical remission
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of our study was to investigate the correlation of fecal calprotectin and lactoferrin levels with MES, UCEIS and ME in patient with UC in clinical remission.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	Correlations between relapse rate within 1 year and magnifying endoscopic stratification
Key secondary outcomes	1. Correlations between fecal calprotectin, lactoferrin and magnifying endoscopic stratification 2. Correlations between fecal marker concentration and relapse rate within 1 year

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	1.UC diagnosed by established criteria, age > 20 2.patients in clinical remission, partial UC-disease activity index of <2 and a bloody stool score of 0 3.patient who was acquired informed consent in advance about taking fecal samples, and using their clinical data for this study
Key exclusion criteria	1.active UC 2.liver disease, kidney disease, heart disease, and other severe complications, all of the cases that were judged unsuitable for endoscopy. 3.pregnancy
Target sample size	100

Research contact person
Name of lead principal investigator	Shoichiro Mine
Organization	Nagasaki university graduate school of Biomedecal Science
Division name	Department of Gastroenterology and hepatology
Address	1-7-1, Sakamoto, Nagasaki City, Nagasaki Japan
TEL	0958197481
Email	hyotan999@yahoo.co.jp

Public contact
Name of contact person	Shoichiro Mine
Organization	Nagasaki university graduate school of Biomedecal Science
Division name	Department of Gastroenterology and hepatology
Address	1-7-1, Sakamoto, Nagasaki City, Nagasaki Japan
TEL	0958197481
Homepage URL
Email	hyotan999@yahoo.co.

Sponsor
Institute	Nagasaki university graduate school of Biomedecal Science Department of Gastroenterology and hepatology
Institute
Department

Funding Source
Organization	Nagasaki university graduate school of Biomedecal Science Department of Gastroenterology and hepatology
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	2017 Year 05 Month 23 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 06 Month 01 Day
Anticipated trial start date	2015 Year 06 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	patients' background: age, sex, diagnosis disease information: diagnosis, treatment details symptoms: Frequency of defecation, degree of bleeding labratory data: leukocyte counts, erythrocyte counts, Hb, platelet counts, CRP image findings: endoscopic and magnifying endoscopic findings Fecal calprotectin, lactoferrin, Hb

Management information
Registered date	2017 Year 05 Month 23 Day
Last modified on	2017 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031459