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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033267
Receipt No. R000037929
Official scientific title of the study Relationship between mucosa associated microbiota in small intestine and bile acid and pathology of Crohn's disease
Date of disclosure of the study information 2018/07/04
Last modified on 2018/07/04

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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