UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041761 |
|---|---|
| Receipt number | R000047655 |
| Scientific Title | Inspection of the safety of OS-1 jelly intake in people with dysphagy |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2023/03/16 14:38:27 |
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Basic information
Public title
Inspection of the safety of OS-1 jelly
intake in people with dysphagy
Acronym
Inspection of the safety of OS-1 jelly
intake in people with dysphagy
Scientific Title
Inspection of the safety of OS-1 jelly
intake in people with dysphagy
Scientific Title:Acronym
Inspection of the safety of OS-1 jelly
intake in people with dysphagy
Region
| Japan |
Condition
Condition
People with suspected dysphagia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety of OS-1 jelly intake
in patients with dysphagia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ingestion availability
Key secondary outcomes
Number of swallows
Time to induce swallowing reflex
Position of bolus at the start of swallowing reflex
Presence or absence of bolus residue
Pharyngeal residue
Penetration Aspiration Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1.drink 5cc OS-1 3 times.
2.drink 5cc OS-1 jelly 3 times.
3.drink 5cc middle thickened water 3 times.
Interventions/Control_2
1.drink 5cc OS-1 3 times.
2.drink 5cc OS-1 jelly 3 times.
3.drink 5cc middle thickened water 3 times.
Interventions/Control_3
1.drink 5cc OS-1 3 times.
2.drink 5cc OS-1 jelly 3 times.
3.drink 5cc middle thickened water 3 times.
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 suspected
Those who have received sufficient explanation before participating in this study and
who have agreed to participate in the study.
Key exclusion criteria
Those who cannot perform videoendoscopic
examination of swallowing
Those who are in poor general condition and
are considered to have a significantly high risk of aspiration
Target sample size
30
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
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
k.yoshimi.gerd@tmd.ac.jp
Sponsor or person
Institute
Graduate School of Medical and Dental
Sciences, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
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 | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.dovepress.com/articles.php?article_id=82114
Publication of results
Published
Result
URL related to results and publications
https://www.dovepress.com/articles.php?article_id=82114
Number of participants that the trial has enrolled
36
Results
The time until the swallowing reflex was induced and the position of the swallowing reflex triggered were significantly earlier for ORS jelly (p=0.012, p=0.001). The incidence of pharyngeal residue was significantly lower with ORS jelly (p=0.002). The Penetration-Aspiration Scale score was similar for both samples (p=0.062), and no aspiration was observed in either sample.
Results date posted
| 2023 | Year | 03 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
36 patients diagnosed with dysphagia based on videoendoscopic evaluation (VE). They received visiting or outpatient care at our university hospital between February and December 2021 and who required VE. Assigned dentists explained the study to their patients when performing the VE and recruited participants. The inclusion
Participant flow
Assigned dentists explained the study to their patients when performing the VE and recruited participants.
Adverse events
None
Outcome measures
Age, sex, primary disease of dysphagia, and Dysphagia Severity Scale (DSS),and Functional Oral Intake Scale (FOIS) scores were extracted from their medical records.
Outcome measures: number of swallows, time until the swallowing reflex was induced, position of the bolus that triggered the swallowing reflex, pharyngeal residue in the vallecula and pyriform sinuses, Penetration-Aspiration scale
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 12 | 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 | 11 | Day |
Last modified on
| 2023 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047655
