UMIN-CTR Clinical Trial

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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