UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040100 |
|---|---|
| Receipt number | 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 | 2024/04/12 11:25:56 |
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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 Aichi Medical Center Nagoya Daini Hospital
Division name
Department of Gastroenterology
Zip code
466-8650
Address
2-9, Myoken-Cho. Showa-Ku, Nagoya
TEL
052-832-1121
kmiyabe@nagoya2.jrc.or.jp
Public contact
Name of contact person
| 1st name | Katsuyuki |
| Middle name | |
| Last name | Miyabe |
Organization
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Division name
Department of Gastroenterology
Zip code
466-8650
Address
2-9, Myoken-Cho. Showa-Ku, Nagoya
TEL
052-832-1121
Homepage URL
kmiyabe@nagoya2.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Institute
Department
Personal name
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 Aichi Medical Center Nagoya Daini Hospital
Address
2-9, Myoken-Cho. Showa-Ku, Nagoya
Tel
052-832-1121
rhase@nagoya2.jrc.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
1378s
Org. issuing International ID_1
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本赤十字社愛知医療センター名古屋第二病院
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
230
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
| 2025 | Year | 10 | Month | 30 | 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
| 2024 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045722
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/10/19 | 腸内細菌研究_研究実施計画書_第3.2版〔案).pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
