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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014151
Receipt No. R000015849
Scientific Title Evaluation of intestinal permeability in patients with chronic liver disease
Date of disclosure of the study information 2014/06/30
Last modified on 2019/06/07

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Basic information
Public title Evaluation of intestinal permeability in patients with chronic liver disease
Acronym Intestinal permeability in patients with chronic liver disease
Scientific Title Evaluation of intestinal permeability in patients with chronic liver disease
Scientific Title:Acronym Intestinal permeability in patients with chronic liver disease
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of intestinal permeability in patients with chronic liver disease
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Influence of intestinal permeabilitiy on the progression of chronic liver disease
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 biopsy
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
80 years-old >
Gender Male and Female
Key inclusion criteria patients with chronic liver disease
Key exclusion criteria platelet counts:50,000/(mm)3 or less
or
PT INR: 2 or more
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Masatoshi
Middle name
Last name Ishigami
Organization Nagoya University Graduate School of Medicine
Division name Gastroentelorogy and Hepatology
Zip code 466-8550
Address Nagoya city Showa-ku Turuma-sho 65
TEL 0527442169
Email y-ishizu@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Yoji
Middle name
Last name ishizu
Organization Nagoya University Graduate School of Medicine
Division name Gastroentelorogy and Hepatology
Zip code 466-8550
Address Nagoya city Showa-ku Turuma-sho 65
TEL 0527442169
Homepage URL
Email y-ishizu@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine, Department of Gastroentelorogy and Hepatology
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine, Department of Gastroentelorogy and Hepatology
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 Ethics Committee
Address Nagoya city Showa-ku Turuma-sho 65
Tel 0527442169
Email ethics@med.nagoya-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
2014 Year 06 Month 30 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 20
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 No longer recruiting
Date of protocol fixation
2014 Year 06 Month 10 Day
Date of IRB
2014 Year 06 Month 10 Day
Anticipated trial start date
2014 Year 06 Month 10 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 03 Day
Last modified on
2019 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015849

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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