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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041744
Receipt No. R000047646
Scientific Title The gut microbiota of critically ill patients
Date of disclosure of the study information 2020/10/01
Last modified on 2020/09/09

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Basic information
Public title The gut microbiota of critically ill patients
Acronym The gut microbiota of critically ill patients
Scientific Title The gut microbiota of critically ill patients
Scientific Title:Acronym The gut microbiota of critically ill patients
Region
Japan

Condition
Condition critically ill patients
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify changes in intestinal flora
Basic objectives2 Others
Basic objectives -Others To clarify changes in intestinal flora
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in intestinal flora
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 Patients admitted to ICU
Key exclusion criteria None
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Motomu
Middle name
Last name Shimaoka
Organization Mie University Graduate School of Medicine
Division name Dept of Molecular Pathobiology and Cell Adhesion Biology
Zip code 514-8507
Address 2-174 Edobashi Tsu-City
TEL 059-231-5036
Email motomushimaoka@gmail.com

Public contact
Name of contact person
1st name EIJI
Middle name
Last name KAWAMOTO
Organization Mie University Graduate School of Medicine
Division name Emergency and Disaster Medicine
Zip code 514-8507
Address 2-174 Edobashi, Tsu 514-8507, Japan
TEL 0592321111
Homepage URL
Email a_2.uk@mac.com

Sponsor
Institute Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization KAKEN
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Mie University Hospital
Address 2-174 Edobashi, Tsu 514-8507, Japan
Tel 059-232-1111
Email a-2@umin.net

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
2020 Year 10 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 Open public recruiting
Date of protocol fixation
2016 Year 02 Month 22 Day
Date of IRB
2016 Year 02 Month 22 Day
Anticipated trial start date
2016 Year 02 Month 22 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We observe changes in the intestinal microbiota obtained from the stools of patients and changes in the data related to severity and vital signs such as blood data and respiratory circulation data of patients.

Management information
Registered date
2020 Year 09 Month 09 Day
Last modified on
2020 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047646

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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