UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The analysis of gut microbiome pre- and post-liver transplantation
Title of the study (Brief title)	The analysis of gut microbiome pre- and post-liver transplantation
Region	Japan

Condition
Condition	Liver transplantation
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the gut microbiome pre- and post- liver transplantation
Basic objectives2	Others
Basic objectives -Others	To examine the contribution of gut microbiome to clinical course
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To clarify the gut microbiome pre- and post- liver transplantation
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Genders do not matter. 2. Patients who who will visit as outpatient or be admitted to Nagasaki university hospital. 3. Patients who will get colonoscopy in health insurance. 4. Patients providing written informed consent with their own will.
Key exclusion criteria	1. Patients with a high bleeding risk. 2. Patients with some diffuse lesions in clarge olon. 3. Patients with severe general complications 4. Patients who were judged to be inappropriate for this study.
Target sample size	50

Research contact person
Name of lead principal investigator	Satoshi Miuma
Organization	Nagasaki University Hospital
Division name	Department of Gastroenterology and Hepatology
Address	Sakamoto 1-7-1, Nagasaki
TEL	0958197481
Email	miuma1002@gmail.com

Public contact
Name of contact person	Satoshi Miuma
Organization	Nagasaki University Hospital
Division name	Department of Gastroenterology and Hepatology
Address	1-7-1 Sakamoto, Nagasaki
TEL	0958197481
Homepage URL
Email	miuma1002@gmail.com

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Nagasaki University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 02 Month 14 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 04 Month 28 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Not particular

Management information
Registered date	2017 Year 02 Month 14 Day
Last modified on	2017 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030029