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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030528
Receipt No. 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 2019/06/24

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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
Middle name
Last name Hirokazu Takahashi
Organization Saga Medical School
Division name Metabolism and Hepatology
Zip code
Address 5-1-1, Nabeshima, Saga
TEL 0952-31-6511
Email takahas2@cc.saga-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirokazu Takahashi
Organization Saga Medical School
Division name Metabolism and Hepatology
Zip code
Address 5-1-1, Nabeshima, Saga
TEL 0952-31-6511
Homepage URL
Email takahas2@cc.saga-u.ac.jp

Sponsor
Institute Saga Medical School, Division of Metabolism and Endocrinology
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
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
2019 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034849

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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