UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040177
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email 3naika@m.ehime-u.ac.jp

Sponsor
Institute Ehime University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045804

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.