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
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
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
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
