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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040100
Receipt No. R000045722
Scientific Title Exploration of bile and gut microbiome with their metabolomics in the bile duct diseases
Date of disclosure of the study information 2020/04/08
Last modified on 2020/10/09

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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


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