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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006468
Receipt No. R000007675
Scientific Title Study for appropriate management of nutrition for patient with swallowing disorder at Dysphagia Severity Scale 4 (accidental aspiration) and 5 (oral problem) - Cross over study using experimental food and conventional food -
Date of disclosure of the study information 2011/10/04
Last modified on 2011/10/04

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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) - Cross over study using experimental food and conventional food -
Acronym Investigation of Experimental food Technology - Short Study - (IET-SS)
Scientific Title Study for appropriate management of nutrition for patient with swallowing disorder at Dysphagia Severity Scale 4 (accidental aspiration) and 5 (oral problem) - Cross over study using experimental food and conventional food -
Scientific Title:Acronym Investigation of Experimental food Technology - Short Study - (IET-SS)
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 food selection affect the amount rate of consumed food, nutrition intake, QOL and nourishment of the patient with dysphagia?
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes amount rate of consumed food, nutrition intake, nourishment, safety of experimental food
Key secondary outcomes QOL

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Experimental food
Interventions/Control_2 Conventional food
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 Dementia
Target sample size 100

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
Email

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 24-1, Otori-chou, Tsu, Mie
TEL 059-252-1555
Homepage URL
Email t-gucci30219@herb.ocn.ne.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

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
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 藤田保健衛生大学 七栗サナトリウム

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007675

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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