UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006472 |
|---|---|
| Receipt number | R000007682 |
| Scientific Title | Study for appropriate management of nutrition for patient with swallowing disorder at Dysphagia Severity Scale 4 (accidental aspiration) and 5 (oral problem) – Investigation of patient eating experimental food for a long period – |
| Date of disclosure of the study information | 2011/10/04 |
| Last modified on | 2011/10/04 19:46:36 |
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Basic information
Public title
Study for appropriate management of nutrition for patient with swallowing disorder at Dysphagia Severity Scale 4 (accidental aspiration) and 5 (oral problem) – Investigation of patient eating experimental food for a long period –
Acronym
Investigation of Experimental food Technology - Long Study - (IET-LS)
Scientific Title
Study for appropriate management of nutrition for patient with swallowing disorder at Dysphagia Severity Scale 4 (accidental aspiration) and 5 (oral problem) – Investigation of patient eating experimental food for a long period –
Scientific Title:Acronym
Investigation of Experimental food Technology - Long Study - (IET-LS)
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Geriatrics | Surgery in general | Rehabilitation medicine |
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Does the long term nutrition by experimental food change the QOL of the patients with dysphagia?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
QOL, Safety of experimental food
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Experimental food
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
DSS 4 or 5
Key exclusion criteria
No limitation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Toba |
Organization
National Center for Geriatrics and Gerontology
Division name
National Hospital for Geriatric Medicine
Zip code
Address
35, Gengo, Morioka-chou, Obu, Aichi
TEL
0562-46-2311
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Higashiguchi |
Organization
Nanakuri Sanatorium, Fujita Health University
Division name
Department of Surgery and Terminal care
Zip code
Address
424-1, Otori-chou, Tsu, Mie
TEL
059-252-1555
Homepage URL
t-gucci30219@herb.ocn.ne.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Minister of Health and Labor
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
藤田保健衛生大学大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 10 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 04 | Day |
Last modified on
| 2011 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007682
