UMIN-CTR Clinical Trial

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