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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028843


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name