UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	SUD; bowel sensory and bowel tight junction study
Title of the study (Brief title)	SUD; bowel sensory and bowel tight junction study
Region	Japan

Condition
Condition	Colonic diverticular disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Pathogenesis of colonic diverticular disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Consider the relationship btween the symptoms and neurotransmitters
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Measurements of mucosal resisance Equipment use period: from Jan 1, 2016 Equipment usage and number and frequency: the one place per case was measured three times at two location(assending and sigmoid) of colon mucosa, and take average
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	10 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with the colonic diverticulums
Key exclusion criteria	Patient contsent can not be obstained
Target sample size	60

Research contact person
Name of lead principal investigator	Noriaki Manabe
Organization	Kawasaki Medical School
Division name	Division of Endoscopy and ltrasonography, Department of Clinical Pathology and Laboratory Medicine
Address	577, Matsushima, Kurashiki 701-0192, Japan
TEL	086-462-1111
Email	n_manabe@hkg.odn.ne.jp

Public contact
Name of contact person	Noriaki Manabe
Organization	Kawasaki Medical School
Division name	Division of Endoscopy and ltrasonography, Department of Clinical Pathology and Laboratory Medicine
Address	577, Matsushima, Kurashiki 701-0192, Japan
TEL	086-462-1111
Homepage URL
Email	n_manabe@hkg.odn.ne.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Kawasaki Medical School
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	2016 Year 03 Month 25 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 01 Month 01 Day
Anticipated trial start date	2016 Year 03 Month 25 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

Management information
Registered date	2016 Year 03 Month 25 Day
Last modified on	2018 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024930