UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041744
Receipt number 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 20:16:44

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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 or person

Institute

Mie University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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