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
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/
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
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
