UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016013
Receipt number R000018612
Scientific Title Clinical study of tube administration speed of viscosity modifiered enteral fomula
Date of disclosure of the study information 2015/01/05
Last modified on 2017/06/22 09:34:55

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Basic information

Public title

Clinical study of tube administration speed of viscosity modifiered enteral fomula

Acronym

tube administration speed of viscosity modifiered enteral fomula

Scientific Title

Clinical study of tube administration speed of viscosity modifiered enteral fomula

Scientific Title:Acronym

tube administration speed of viscosity modifiered enteral fomula

Region

Japan


Condition

Condition

Tube feeding

Classification by specialty

Medicine in general Surgery in general Oto-rhino-laryngology
Oral surgery Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The corelation between in vitro and in vivo examination of administration speed in tube feeding with long catheter example of nasogastric catheter, percutaneous transesophageal catheter,
and jejunal catheter.

Basic objectives2

Others

Basic objectives -Others

Comfirmation of clinical side effect.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Administration speed comparing with in vitro study

Key secondary outcomes

Change of urinal pH.change of body weight. Frequency of diarrhea and constipation. Change of body temparature. The room temparature.


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

The objects are administerd viscosity controlled enteral formula.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The patients who undergo tube feeding.The subject who recognized the examination and is able to give the agreement. The patients who is undergoing tube feeding with nasogastric catheter 5 days or longer.

Key exclusion criteria

The patients who are cirtified as contraindication case of this study by attending doctor.
The patients out of indication for tube feeding.
The patients have a complication durig the study.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naohiro Washizawa

Organization

Toho University Omori Medical Center

Division name

Nutrition Therapy Center

Zip code


Address

Omori-Nishi6-11-1,Ota-ku,Tokyo

TEL

03-3762-4151

Email

washi@med.toho-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naohiro Washizawa

Organization

Toho University Omori Medical Center

Division name

Nutrition Therapy Center

Zip code


Address

Omori-Nishi6-11-1,Ota-ku,Tokyo

TEL

03-3762-4151

Homepage URL


Email

washi@med.toho-u.ac.jp


Sponsor or person

Institute

VF researching group

Institute

Department

Personal name



Funding Source

Organization

Toho university school of medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tanashi hospital, Clover hospital, ASAHI KASEI PHARMA CORPORATION

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

東邦大学医療センター大森病院、田無病院、クローバーホスピタル


Other administrative information

Date of disclosure of the study information

2015 Year 01 Month 05 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

2014 Year 12 Month 08 Day

Date of IRB


Anticipated trial start date

2014 Year 12 Month 22 Day

Last follow-up date

2015 Year 06 Month 30 Day

Date of closure to data entry

2015 Year 07 Month 15 Day

Date trial data considered complete

2015 Year 08 Month 02 Day

Date analysis concluded

2015 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2014 Year 12 Month 20 Day

Last modified on

2017 Year 06 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018612


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name