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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041674
Receipt No. R000047562
Scientific Title Effect and safety of thickened carbonated beverages in patient with dysphagia
Date of disclosure of the study information 2021/01/01
Last modified on 2021/03/05

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Basic information
Public title Effect and safety of thickened carbonated beverages in patient with dysphagia
Acronym Effect and safety of thickened carbonated beverages in patient with dysphagia
Scientific Title Effect and safety of thickened carbonated beverages in patient with dysphagia
Scientific Title:Acronym Effect and safety of thickened carbonated beverages in patient with dysphagia
Region
Japan

Condition
Condition dysphagia
Classification by specialty
Rehabilitation medicine Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to verify the effectiveness and safety of thickened carbonated beverages in patients with dysphagia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Videoendoscopic examination of swallowing(VE) is performed to evaluate swallowing function when ingesting thickened carbonated beverage and normal thickened water.
We investigate whether the carbonic acid affects the aspiration, pharyngeal residues, and swallowing reflex.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 1.drink 5cc thickened carbonated beverage 3 times.
2.drink 5cc normal thickened water 3 times.
Interventions/Control_2 1.drink 5cc normal thickened water 3 times.
2.drink 5cc thickened carbonated beverage 3 times.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patient with dysphagia
patient with dysphagia suspected
Key exclusion criteria unstable physical or mental status
unable to perform VE due to severe dysphagia
Target sample size 34

Research contact person
Name of lead principal investigator
1st name Kazuharu
Middle name
Last name Nakagawa
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Depertment of Dysphagia rehabiritation
Zip code 1138510
Address 1-5-45, Yushima, Bunkyo, Tokyo 113-8510, Japan
TEL 0358034560
Email nakagerd@tmd.ac.jp

Public contact
Name of contact person
1st name Kanako
Middle name
Last name Yoshimi
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Depertment of Dysphagia rehabiritation
Zip code 1138510
Address 1-5-45, Yushima, Bunkyo, Tokyo 113-8510, Japan
TEL 0358035562
Homepage URL
Email k.yoshimi.gerd@tmd.ac.jp

Sponsor
Institute Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Address 1-5-45, Yushima, Bunkyo, Tokyo 113-8510, Japan
Tel 0358035562
Email k.yoshimi.gerd@tmd.ac.jp

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

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 01 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 Open public recruiting
Date of protocol fixation
2020 Year 09 Month 03 Day
Date of IRB
2020 Year 01 Month 25 Day
Anticipated trial start date
2020 Year 11 Month 01 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 03 Day
Last modified on
2021 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047562

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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