UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030528 |
|---|---|
| Receipt number | R000034849 |
| Scientific Title | Association between periodontitis-related bacteria in ascites and pathogenesis of liver cirrhosis. |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2020/12/24 12:24:20 |
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Basic information
Public title
Association between periodontitis-related
bacteria in ascites and pathogenesis of liver cirrhosis.
Acronym
Periodontitis and liver cirrhosis
Scientific Title
Association between periodontitis-related
bacteria in ascites and pathogenesis of liver cirrhosis.
Scientific Title:Acronym
Periodontitis and liver cirrhosis
Region
| Japan |
Condition
Condition
Liver cirrhosis (decompensated state)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aim to identify the effect of periodontitis-related bacterial infection of ascites on pathogenesis and prognosis of liver cirrhosis.
Basic objectives2
Others
Basic objectives -Others
Identification of periodontitis-related bacteria in ascites and correlation analysis among infection, liver function and mortality.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence of periodontitis-related bacteria
Key secondary outcomes
Correlation among infection of periodontitis-related bacteria in ascites , liver function and mortality.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with cirrhosis with ascites, which need to be clinically tested.
Key exclusion criteria
noen
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Takahashi |
Organization
Saga Medical School
Division name
Metabolism and Hepatology
Zip code
8498501
Address
5-1-1, Nabeshima, Saga
TEL
0952342362
takahas2@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Takahashi |
Organization
Saga Medical School
Division name
Metabolism and Hepatology
Zip code
8498501
Address
5-1-1, Nabeshima, Saga
TEL
0952-31-6511
Homepage URL
takahas2@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga Medical School, Division of Metabolism and Endocrinology
Institute
Department
Personal name
Funding Source
Organization
Saga Medical School, Division of Metabolism and Endocrinology
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
Clinical Study Center, Faculty of Medicine, Saga University
Address
5-1-1 Nabeshima
Tel
0952-31-6511
clinstudycenter@mail.admin.saga-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
| 2018 | Year | 03 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2017 | Year | 12 | Month | 22 | Day |
Last modified on
| 2020 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034849
