UMIN-CTR Clinical Trial

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
Institute	Hokkaido University Hospital
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022020