UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012240 |
|---|---|
| Receipt number | 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 16:16:24 |
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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
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
t_oshima@chiba-u.jp
Sponsor or person
Institute
Dept of Emergency and Critical Care Medicine, Chiba University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014303
