UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The analysis of mucosa-associated microbiota in IBD
Title of the study (Brief title)	The analysis of mucosa-associated microbiota in IBD
Region	Japan

Condition
Condition	inflammatory bowel disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the components of mucosa-associated in IBD
Basic objectives2	Others
Basic objectives -Others	To assess the impact of mucosa-associated microbiota on the pathology of IBD
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The components of mucosa-associated microbiota and the impact on the pathology of IBD
Key secondary outcomes	The association of mucosa-associated microbiota and treatment history

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	IBD patients who undergoing gastrointestinal endoscopy Other patients who undergoing gastrointestinal endoscopy
Key exclusion criteria	Patients who reject to participate in this study Patients with infectious disease that requires notification under the Infectious Diseases Control Law Patients who are considered to be unsuitable to this study for any other reason
Target sample size	60

Research contact person
Name of lead principal investigator	Akira Andoh
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology, Department of Medicine
Address	Setatsukinowa, Otsu
TEL	077-548-2217
Email	andoh@belle.shiga-med.ac.jp

Public contact
Name of contact person	Atsushi Nishida
Organization	Shiga University of Medical Science
Division name	Division of Gastroenterology, Department of Medicine
Address	Setatsukinowa, Otsu
TEL	077-548-2217
Homepage URL
Email	atsuda@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	None
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 11 Month 07 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 07 Day
Anticipated trial start date	2016 Year 11 Month 07 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	We aim to clarify the structure and function analysis of mucosa-associated microbiota in patients with inflammatory bowel disease.

Management information
Registered date	2016 Year 11 Month 07 Day
Last modified on	2017 Year 06 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028467