UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024837 |
|---|---|
| Receipt number | 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 | 2022/05/23 15:18:53 |
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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 | Tsunamasa |
| Middle name | |
| Last name | Watanabe |
Organization
St.Marianna University school of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
216-8511
Address
Kanagawa, Kawasaki 216-8511, Japan
TEL
044-977-8111
twatanab@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryuta |
| Middle name | |
| Last name | Shigefuku |
Organization
St.Marianna University school of Medicine
Division name
Division of Gastroenterology and Hepatology
Zip code
216-8511
Address
Kanagawa, Kawasaki 216-8511, Japan
TEL
044-977-8111
Homepage URL
r2shigefuku@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University school of Medicine
Institute
Department
Personal name
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
St.Marianna University school of Medicine
Address
Kanagawa, Kawasaki 216-8511, Japan
Tel
044-977-8111
twatanab@marianna-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
| 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
28
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
| 2016 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
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
| 2022 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028582
| 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 |
