UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046319 |
|---|---|
| Receipt number | R000052859 |
| Scientific Title | A Study on the effects of Complementary and integrative medical intervention of food on people requiring support. |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/12/11 12:15:44 |
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Basic information
Public title
A Study on the effects of Complementary and integrative medical intervention of food on people requiring support.
Acronym
A Study on the effects of Complementary and integrative medical intervention of food on people requiring support.
Scientific Title
A Study on the effects of Complementary and integrative medical intervention of food on people requiring support.
Scientific Title:Acronym
A Study on the effects of Complementary and integrative medical intervention of food on people requiring support.
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Rehabilitation medicine | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.Analysis of changes in the gut microbiota of people requiring support due to intake of fermented foods.
2.Evaluation of the effects of carbonated thickened water on swallowing exercises.
3.Development of a swallowing assessment tool using yokan(azuki bean jelly).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Gut microbiota one month after intake of fermented foods
2.Duration of time to establish oral intake and hospital stay
3.Availability of solid food intake
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Carbonated thickened water intake group
Interventions/Control_2
Normal thickened water intake group
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with acute dysphagia who have not started oral intake.
Key exclusion criteria
Those who are considered to be unable to carry out the exercise safely. Those whose general condition is not stable. Those who have not consented to the research.
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Kazuharu |
| Middle name | |
| Last name | Nakagawa |
Organization
Tokyo Medical and Dental University
Division name
Department of Dysphagia Rehabilitation
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo, Tokyo 113-8549, Japan
TEL
03-5803-4560
nakagerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kazuharu |
| Middle name | |
| Last name | Nakagawa |
Organization
Tokyo Medical and Dental University
Division name
Department of Dysphagia Rehabilitation
Zip code
113-8549
Address
1-5-45, Yushima, Bunkyo, Tokyo 113-8549, Japan
TEL
03-5803-4560
Homepage URL
nakagerd@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
AMED-CREST,AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Committee, School of Dentistry, Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo, Tokyo 113-8549, Japan
Tel
03-5803-5404
d-hyoka.adm@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
| 2022 | Year | 04 | 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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052859
