UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000025075 |
|---|---|
| Receipt number | R000028843 |
| Scientific Title | Effects of early enteral nutrition in acute stroke patients: an open-label randomized study |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2020/12/03 11:10:46 |
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Basic information
Public title
Effects of early enteral nutrition in acute stroke patients: an open-label randomized study
Acronym
Early enteral nutrition in acute stroke patients
Scientific Title
Effects of early enteral nutrition in acute stroke patients: an open-label randomized study
Scientific Title:Acronym
Early enteral nutrition in acute stroke patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of early enteral feeding on systemic inflammation in acute stroke patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of the serum levels of inflammatory markers (interleukin-6, high sensitivity CRP) , LPS binding protein and an intestinal permeability marker (zonulin) from the first to seventh and fourteenth feeding days.
Key secondary outcomes
Frequency of infection
National institute of health stroke scale
Modified Rankin Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Early enteral nutrition via a nasogastric tube with an oligomeric formula containing hydrolyzed whey protein within 24 hours after admission.
Interventions/Control_2
Enteral nutrition with a polymeric formula via a nasogastric tube.
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
1. Stroke patients within 24 hours from onset.
2. An inadequate or unsafe oral intake.
Key exclusion criteria
1. Use of antibiotics within 3 months
2. Infection at admission
3. Malignant tumor
4. Autoimmune diseases
5. Postoperative state due to gastrointestinal disorders
6. Liver or renal failure
7. Poorly controlled diabetes
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Yamashiro |
Organization
Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
Address
2-1-1 Hongo, Bukyo-ku, Tokyo
TEL
03-3813-3111
kazuo-y@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Yamashiro |
Organization
Juntendo University School of Medicine
Division name
Department of Neurology
Zip code
Address
2-1-1 Hongo, Bukyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
kazuo-y@juntendo.ac.jp
Sponsor or person
Institute
Department of Neurology, Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology, Juntendo University School of Medicine
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
順天堂大学医学部付属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 30 | Day |
Last modified on
| 2020 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028843
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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