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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name