UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between mucosa associated microbiota in small intestine and bile acid and pathology of Crohn's disease
Title of the study (Brief title)	Relationship between mucosa associated microbiota in small intestine and bile acid and pathology of Crohn's disease
Region	Japan

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

Objectives
Narrative objectives1	We clarify how the intestinal microbiota in the intestinal mucosa and the bile acid in the intestinal tract affect the pathology of Crohn's disease.
Basic objectives2	Others
Basic objectives -Others	We clarify how the intestinal microbiota in the intestinal mucosa and the bile acid in the intestinal tract affect the pathology of Crohn's disease.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Frequency of intestinal resection, stenosis and fistula
Key secondary outcomes	Relationship between the pathology of Crohn's disease(Disease type, diseased site, disease activity score of Crohn's disease), mucosa associated microbiota and bile acid

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Collect oral cavity and intestinal mucosa of control patients at small intestine endoscopy
Interventions/Control_2	Collect oral and intestinal mucosa of inflammatic crohn's disease patients at small intestine endoscopy
Interventions/Control_3	Collect oral and intestinal mucosa of stenotic Crohn's disease patients at small intestine endoscopy
Interventions/Control_4	Collect oral and intestinal mucosa of fistula type Crohn's disease patients at small intestine endoscopy
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient undergoing small intestine endoscopy
Key exclusion criteria	Patients with malignancy Patients with pregnancy
Target sample size	80

Research contact person
Name of lead principal investigator	Morita Yasuhiro
Organization	Shiga university of medical science
Division name	Gastroenterology
Address	Tukinowa otsu shiga Japan
TEL	077-548-2111
Email	moritay@belle.shiga-med.ac.jp

Public contact
Name of contact person	Morita Yasuhiro
Organization	Shiga university of medical science
Division name	Gastroenterology
Address	Tukinowa otsu shiga Japan
TEL	077-548-2111
Homepage URL
Email	moritay@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga university of medical science
Institute
Department

Funding Source
Organization	Self funding
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	滋賀医科大卓（滋賀県）

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 04 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 06 Month 29 Day
Anticipated trial start date	2018 Year 06 Month 29 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	2018 Year 07 Month 04 Day
Last modified on	2018 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037929