UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014151 |
|---|---|
| Receipt number | 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 | 2022/12/09 12:20:11 |
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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
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
y-ishizu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Gastroentelorogy and Hepatology
Institute
Department
Personal name
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
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
no
Publication of results
Unpublished
Result
URL related to results and publications
no
Number of participants that the trial has enrolled
20
Results
Atrophy of the small intestinal mucosa was observed in patients with chronic liver disease, but the relationship between pathology and mucosal morphology could not be shown.
Results date posted
| 2022 | Year | 12 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
liver cirrhosis
Participant flow
Only patients with consent were included in the study.
Adverse events
none
Outcome measures
Relationship between the morphology of the small intestinal mucosa and liver function
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
| 2022 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015849
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
