UMIN-CTR Clinical Trial

Basic information
Public title	Exploration of bile and gut microbiome with their metabolomics in the bile duct diseases
Acronym	Yagoto microbiome study
Scientific Title	Exploration of bile and gut microbiome with their metabolomics in the bile duct diseases
Scientific Title:Acronym	Gut/Bile microbiome study
Region	Japan

Condition
Condition	Patients who will undergo endoscopic retrograde cholangioscopy
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to elucidate the association between microbiome profiles and its metabolomics by analyses of gut and stool microbiome, and their metabolomics in patients with bile duct diseases.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clarification of gut and microbiome spectrum along with relevance of short chain fatty acids and bile acids in each bile duct disease
Key secondary outcomes

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Subjects who will undergo endoscopic retrograde cholangiography 2. 18 years and older 3. Subjects who signed up the consent form of the study.
Key exclusion criteria	1. Abnormal postsurgical anatomy hard to obtain bile sample. 2. Subjects who disagree with the study or withdraw the agreement of the study. 3. Subjects who are incapable of filling out a questionnaire in the study.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Katsuyuki Middle name Last name Miyabe
Organization	Japanese Red Cross Nagoya Daini Hospital
Division name	Dept. of Gastroenterology
Zip code	466-8650
Address	2-9, Myoken-Cho. Showa-Ku, Nagoya
TEL	052-832-1121
Email	kmiyabe@nagoya2.jrc.or.jp

Public contact
Name of contact person	1st name Katsuyuki Middle name Last name Miyabe
Organization	Japanese Red Cross Nagoya Daini Hospital
Division name	Dept. of Gastroenterology
Zip code	466-8650
Address	2-9, Myoken-Cho. Showa-Ku, Nagoya
TEL	052-832-1121
Homepage URL
Email	kmiyabe@nagoya2.jrc.or.jp

Sponsor
Institute	Japanese Red Cross Nagoya Daini Hospital
Institute
Department

Funding Source
Organization	Department of Community-based Medical Education and Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Japan
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japanese Red Cross Nagoya Daini Hospital
Address	2-9, Myoken-Cho. Showa-Ku, Nagoya
Tel	052-832-1121
Email	rhase@nagoya2.jrc.or.jp

Secondary IDs
Secondary IDs	NO
Study ID_1	1378s
Org. issuing International ID_1	Japanese Red Cross Nagoya Daini Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	名古屋第二赤十字病院 名古屋市立大学大学院

Other administrative information
Date of disclosure of the study information	2020 Year 04 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2020 Year 01 Month 27 Day
Date of IRB	2020 Year 01 Month 27 Day
Anticipated trial start date	2020 Year 03 Month 01 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	IRB# 1378s

Management information
Registered date	2020 Year 04 Month 08 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045722

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.