UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Correlation analysis between pouchitis disease activity and measuring fecal concentration of calprotectin
Title of the study (Brief title)	Correlation analysis between pouchitis and fecal calprotectin
Region	Japan

Condition
Condition	pouchitis
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The object of this study is to analyze the correlation between the concentration of fecal calprotectin and pouchitis after restorative proctocolectomy in patients with ulcerative colitis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Onset of pouchitis after restorative proctocolectomy in patients with ulcerative colitis
Key secondary outcomes	Concentrations of fecal calprotectin before and after restorative proctocolectomy and treatment for pouchitis

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	Patients with initial pouchitis after restorative proctocolectomy in patients with ulcerative colitis.
Key exclusion criteria	1, Patients without agreement of this study 2, Patients with pregnant or its suspicious 3, Patients with drug allergy for ciprofloxacin
Target sample size	15

Research contact person
Name of lead principal investigator	Motoi Uchino
Organization	Hyogo College of Medicine
Division name	Department of Inflammatory Bowel Disease
Address	1-1, Mukogawacho, Nishinomiya, Hyogo, Japan
TEL	0798-45-6371
Email	motoi.uchino@nifty.ne.jp

Public contact
Name of contact person	Motoi Uchino
Organization	Hyogo College of Medicine
Division name	Department of Inflammatory Bowel Disease
Address	1-1, Mukogawacho, Nishinomiya, Hyogo, Japan
TEL	0798-45-6371
Homepage URL
Email	motoi.uchino@nifty.ne.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Outside Japan
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	2014 Year 10 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 09 Month 01 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2020 Year 08 Month 31 Day
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	We could not recruit the suitable patients. Therefore, this examinations and study were terminated.
Other related information	No other related on formation.

Management information
Registered date	2014 Year 08 Month 21 Day
Last modified on	2017 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017352