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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012240
Receipt No. R000014303
Scientific Title Evaluation of feces condition using YH Flore for ICU patients
Date of disclosure of the study information 2013/11/07
Last modified on 2018/07/25

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Basic information
Public title Evaluation of feces condition using YH Flore for ICU patients
Acronym Evaluation of feces condition using YH Flore for ICU patients
Scientific Title Evaluation of feces condition using YH Flore for ICU patients
Scientific Title:Acronym Evaluation of feces condition using YH Flore for ICU patients
Region
Japan

Condition
Condition ICU of 18 years or older in age, with diarrhea due to enteral nutrition
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate feces condition change by using YH flore
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes change in feces condition after YH Flore administration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 adminiatration of YH flore
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ICUpatients with diarrehea
Key exclusion criteria renal failure
younger than 18year in age
allergic to milk or soybeans
pregnancy
otherwise inapplicable
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeto Oda
Organization Chiba University Graduate School of Medicine
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 1-8-1 Inohana Chuou-ku, Chiba City
TEL 043-222-7171
Email odas@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taku Oshima
Organization Chiba University Hospital
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 1-8-1 Inohana Chuou-ku, Chiba City
TEL 043-222-7171
Homepage URL
Email t_oshima@chiba-u.jp

Sponsor
Institute Dept of Emergency and Critical Care Medicine, Chiba University Hospital
Institute
Department

Funding Source
Organization Dept of Emergency and Critical Care Medicine, Chiba University Hospital
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
2013 Year 11 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2013 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 09 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

Management information
Registered date
2013 Year 11 Month 07 Day
Last modified on
2018 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014303

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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