UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040177 |
|---|---|
| Receipt number | R000045804 |
| Scientific Title | Studies on the effects of gut microbiota and bile acid composition on the pathology of liver diseases |
| Date of disclosure of the study information | 2020/04/18 |
| Last modified on | 2020/04/16 14:24:05 |
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Basic information
Public title
Studies on the effects of gut microbiota and bile acid composition on the pathology of liver diseases
Acronym
Studies on the effects of gut microbiota and bile acid composition on the pathology of liver diseases
Scientific Title
Studies on the effects of gut microbiota and bile acid composition on the pathology of liver diseases
Scientific Title:Acronym
Studies on the effects of gut microbiota and bile acid composition on the pathology of liver diseases
Region
| Japan |
Condition
Condition
Primary Biliary Cholangitis
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify gut microbial dysbiosis in the small intestine of primary biliary cholangitis.
Basic objectives2
Others
Basic objectives -Others
To clarify bile acid composition and bile acid transporter in the small intestine of primary biliary cholangitis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diversity of gut microbiome and identification of characteristic bacterial species in patients with primary biliary cholangitis and healthy volunteers
Key secondary outcomes
Fractionation of bile acid composition in the terminal ileum of patients with primary biliary cholangitis and healthy volunteers
Expression of bile acid transporter in terminal ileum of patients with primary biliary cholangitis and healthy volunteers
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Liver disease patients (priority to primary biliary cholangitis)
Patients with non-liver disease scheduled for endoscopy
Key exclusion criteria
Patients who do not agree with the study.
Patients who cannot understand the explanation of the study.
Patients who cannot undergo colonoscopy due to poor general condition.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Kitahata |
Organization
Ehime University Graduate School
Division name
Digestive / Endocrine / Metabolism Internal Medicine
Zip code
791-0295
Address
454 Shizukawa, Touon City, Ehime Prefecture
TEL
089-960-5308
3naika@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Kitahata |
Organization
Ehime University Graduate School
Division name
Digestive / Endocrine / Metabolism Internal Medicine
Zip code
791-0295
Address
454 Shizukawa, Touon City, Ehime Prefecture
TEL
089-960-5308
Homepage URL
3naika@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Ehime University
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
Ehime University Hospital
Address
454 Shizukawa, Touon City, Ehime Prefecture
Tel
089-960-5914
cttc@m.ehime-u.ac.jp
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
| 2020 | Year | 04 | Month | 18 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with primary bile cholangitis and non-liver disease who underwent colonoscopy at our hospital between January 2016 and December 2020 and who met the selection criteria were targeted. Cross-sectional studies will be conducted with the evaluation items as mucosa-associated microbiome and intestinal juice bile acid composition at the terminal ileum and blood bile acid composition. The gut microbiome are collected from the terminal ileum using brush forceps under colonoscopy, and fecal samples are also collected and analyzed by a next-generation sequencer. Intestinal fluid is also collected endoscopically from the terminal ileum, and the intestinal fluid bile acid composition is also analyzed.
Management information
Registered date
| 2020 | Year | 04 | Month | 16 | Day |
Last modified on
| 2020 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045804
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
