UMIN-CTR Clinical Trial

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
Email	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
Email	kazuo-y@juntendo.ac.jp

Sponsor
Institute	Department of Neurology, Juntendo University School of Medicine
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028843