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

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

424-1, Otori-chou, Tsu, Mie

TEL

059-252-1555

Homepage URL


Email

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


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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name