UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of tube administration speed of viscosity modifiered enteral fomula
Title of the study (Brief title)	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	Naohiro Washizawa
Organization	Toho University Omori Medical Center
Division name	Nutrition Therapy Center
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	Naohiro Washizawa
Organization	Toho University Omori Medical Center
Division name	Nutrition Therapy Center
Address	Omori-Nishi6-11-1,Ota-ku,Tokyo
TEL	03-3762-4151
Homepage URL
Email	washi@med.toho-u.ac.jp

Sponsor
Institute	VF researching group
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 12 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018612