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Recruitment status
Unique ID issued by UMIN UMIN000021882
Receipt No. R000025229
Scientific Title The effect of alpha-defensin on bacterial translocation in patients with acute pancreatitis
Date of disclosure of the study information 2016/04/12
Last modified on 2016/04/12

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Basic information
Public title The effect of alpha-defensin on bacterial translocation in patients with acute pancreatitis
Acronym Acute pancreatitis and alpha-defensin
Scientific Title The effect of alpha-defensin on bacterial translocation in patients with acute pancreatitis
Scientific Title:Acronym Acute pancreatitis and alpha-defensin
Region
Japan

Condition
Condition Acute pancreatitis
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate an effect of alpha-defensin on bacterial translocation in patients with acute pancreatitis
Basic objectives2 Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of alpha-defensin in serum and stool
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 Acute pancreatitis
Key exclusion criteria Patient refusal
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazumichi Kawakubo
Organization Hokkaido University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address Kita 15 Nishi7, Kita-ku, Sapporo
TEL 011-716-1161
Email kkawakubo-gi@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumichi Kawakubo
Organization Hokkaido University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address Kita 15 Nishi7, Kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email kkawakubo-gi@umin.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

Funding Source
Organization Self-funding
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 04 Month 12 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
Date of protocol fixation
2015 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2016 Year 04 Month 12 Day
Last modified on
2016 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025229

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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