UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019043
Receipt number R000022020
Scientific Title The analysis of the impact of alfa-defensin on bacterial translocation in chronic liver disease
Date of disclosure of the study information 2015/09/24
Last modified on 2022/03/10 14:54:50

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Basic information

Public title

The analysis of the impact of alfa-defensin on bacterial translocation in chronic liver disease

Acronym

The analysis of the impact of alfa-defensin on bacterial translocation in chronic liver disease

Scientific Title

The analysis of the impact of alfa-defensin on bacterial translocation in chronic liver disease

Scientific Title:Acronym

The analysis of the impact of alfa-defensin on bacterial translocation in chronic liver disease

Region

Japan


Condition

Condition

Chronic liver disease

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The analysis of the impact of alfa-defensin on bacterial translocation in chronic liver disease patient bacteriologically and biochemically

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Quantification of alfa-defensin using by ELISA

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. The age of 20 years or older at the time of obtaining informed consent
2. obtained written informed consent

Key exclusion criteria

1. Patient severe liver dysfunction
2. Other patients by whom principal investigator has determined to be inappropriate as a subject

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Kenichi
Middle name
Last name Morikawa

Organization

Hokkaido University Hospital

Division name

Gastroenterology and Hepatology

Zip code

060-8648

Address

Kita 15, Nishi 7, Kita-ku, Sapporo-shi, Hokkaido

TEL

011-716-1161

Email

kenichi.morikawa@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Kenichi
Middle name
Last name Morikawa

Organization

Hokkaido University Hospital

Division name

Gastroenterology and Hepatology

Zip code

060-8648

Address

Kita 15, Nishi 7, Kita-ku, Sapporo-shi, Hokkaido

TEL

011-716-1161

Homepage URL

http://halo.med.hokudai.ac.jp/group/-/hepatology/

Email

kenichi.morikawa@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Hospital

Institute

Department

Personal name



Funding Source

Organization

Hokkaido University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Cell Biological Science, Department of Functional Life Sciences, Hokkaido University Faculty of Advanced Life Science

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hokkaido University Hospital Clinical Research and Medical Innovation Center

Address

Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido

Tel

011-706-7636

Email

crjimu@huhp.hokudai.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

北海道大学病院(北海道)、北海道大学大学院先端生命科学研究院(北海道)


Other administrative information

Date of disclosure of the study information

2015 Year 09 Month 24 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

250

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

A patent is pending.

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

Completed

Date of protocol fixation

2015 Year 07 Month 30 Day

Date of IRB

2015 Year 07 Month 30 Day

Anticipated trial start date

2015 Year 09 Month 24 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 09 Month 21 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information

an observational study with chronic liver injury patient


Management information

Registered date

2015 Year 09 Month 16 Day

Last modified on

2022 Year 03 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022020


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name