UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043536 |
|---|---|
| Receipt number | R000046810 |
| Scientific Title | Study on the correlation between intestinal microbiota and portal vein thrombosis and cirrhosis |
| Date of disclosure of the study information | 2021/03/05 |
| Last modified on | 2021/03/05 20:54:34 |
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Basic information
Public title
Study on the correlation between intestinal microbiota and portal vein thrombosis and cirrhosis
Acronym
Study on intestinal flora and portal vein thrombosis
Scientific Title
Study on the correlation between intestinal microbiota and portal vein thrombosis and cirrhosis
Scientific Title:Acronym
Study on intestinal flora and portal vein thrombosis
Region
| Japan |
Condition
Condition
Portal vein thrombosis, Liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze the correlation between intestinal flora and portal vein thrombosis and cirrhosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analyze the correlation between intestinal flora and the occurrence of portal vein thrombosis and anticoagulant therapeutic effect
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Anticoagulation therapy
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
Portal vein thrombosis
Liver Cirrhosis
Key exclusion criteria
Intestinal infection
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Takatori |
Organization
Kanazawa University
Division name
Department of Gastroenterology
Zip code
920-8641
Address
13-1.Takara-machi, Kanazawa
TEL
0762652235
hajimetakatori@gmail.com
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Takatori |
Organization
Kanazawa University
Division name
Department of Gastroenterology
Zip code
920-8641
Address
13-1.Takara-machi, Kanazawa
TEL
0762652235
Homepage URL
hajimetakatori@gmail.com
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
Medical ethics committee of Kanazawa University
Address
13-1.Takara-machi, Kanazawa
Tel
0762652235
hajimetakatori@gmail.com
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
金沢大学附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 05 | Day |
Last modified on
| 2021 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046810
