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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024837
Receipt No. R000028582
Scientific Title The relationship between intestinal microbioma and liver disease by direct collecing portal venous blood
Date of disclosure of the study information 2016/11/15
Last modified on 2016/11/15

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Basic information
Public title The relationship between intestinal microbioma and liver disease by direct collecing portal venous blood
Acronym The relationship between intestinal microbioma and liver disease by direct collecing portal venous blood
Scientific Title The relationship between intestinal microbioma and liver disease by direct collecing portal venous blood
Scientific Title:Acronym The relationship between intestinal microbioma and liver disease by direct collecing portal venous blood
Region
Japan

Condition
Condition liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the relationship between liver disease and intestinal microbiota.
Basic objectives2 Others
Basic objectives -Others To evaluate bactrerial featrure in the portal venous blood and stool.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To identify the microbiota collerated with liver 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
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria liver disease,liver cirrhosis
non-cirrhotic portal hypertension
(idiopatic potral hypertension, oxaliptatin induced sinusiodal obstraction syndrome, etc)
Key exclusion criteria 1.Patients with severe heart, kedney and liver disease.
2.Patients with allergy of contrast agent
3.Patients during pregnancy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsunamasa Watanabe
Organization St.Marianna University school of Medicine
Division name Division of Gastroenterology and Hepatology
Zip code
Address Kanagawa, Kawasaki 216-8511, Japan
TEL 044-977-8111
Email twatanab@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryuta Shigefuku
Organization St.Marianna University school of Medicine
Division name Division of Gastroenterology and Hepatology
Zip code
Address Kanagawa, Kawasaki 216-8511, Japan
TEL 044-977-8111
Homepage URL
Email r2shigefuku@marianna-u.ac.jp

Sponsor
Institute St.Marianna University school of Medicine
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Reseach
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 11 Month 15 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
Date of protocol fixation
2016 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2016 Year 11 Month 15 Day
Last modified on
2016 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028582

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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