UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046422 |
|---|---|
| Receipt number | R000052973 |
| Scientific Title | Study on the evaluation of mucosal ciliary transport function using endoscopy |
| Date of disclosure of the study information | 2021/12/21 |
| Last modified on | 2021/12/21 11:02:35 |
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Basic information
Public title
Study on the evaluation of mucosal ciliary transport function using endoscopy
Acronym
Study on the evaluation of mucosal ciliary transport function
Scientific Title
Study on the evaluation of mucosal ciliary transport function using endoscopy
Scientific Title:Acronym
Study on the evaluation of mucosal ciliary transport function
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidating the effects of the use of thickeners on the mucociliary transport function
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate within 1 hour. Consider whether mucociliary transport will require more time.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Thicken water made with thickener and saccharin granules as solvent is placed in the nasal cavity and saccharin time is measured.
Nectar-like thickened water (with low viscosity) and honey-like thickened water (with high viscosity) were prepared using a starch-based thickening agent (Thick&Easy, Hormel) or xanthan-gum-based thickening agent (Thicken Up Clear, Nestle). This resulted in a total of four types of thickened water samples. The nectar-like and honey-like thickened water samples were prepared according to the methods specified by the manufacturer.
3 mg of saccharin and 8 mg of colorant (green food dye, Kyoritsu Foods Co., Ltd.) were dissolved in 1 ml of purified water or one of the four types of thickened water samples, resulting in five types of saccharin solutions: 1. a solution without a thickening agent, 2. a starch-based nectar-like solution, 3. a starch-based honey-like solution, 4. a xanthan-gum-based nectar-like solution, and 5. a xanthan-gum-based honey-like solution.
The subjects were asked to participate in the study for any three days during the study period. The saccharin time was measured using one type of saccharin solution on the first day and two types on each of the second and third days. At the time of each measurement, one of five types of saccharin solutions was randomly assigned so that all the five types would be tested individually.
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
| 24 | years-old | <= |
Age-upper limit
| 42 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults who consented to participate in this study.
Key exclusion criteria
Those who had a cold or acute respiratory illness within 2 weeks of the study, those with a history of chronic rhinitis or chronic sinusitis, those with anatomical malformations of the nose, smokers, and those taking drugs were not included in the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kanji |
| Middle name | |
| Last name | Nohara |
Organization
Graduate School of Dentistry Osaka University
Division name
Department of Oral Facial Disorders
Zip code
565-0871
Address
1-8, Yamadaoka, Suita, Osaka, Japan
TEL
0668792278
nohara@dent.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kanji |
| Middle name | |
| Last name | Nohara |
Organization
Graduate School of Dentistry Osaka University
Division name
Department of Oral Facial Disorders
Zip code
565-0871
Address
1-8, Yamadaoka, Suita, Osaka
TEL
0668792278
Homepage URL
nohara@dent.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
None
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 Dentistry Osaka University Division for Oral-Facial Disorders
Address
1-8, Yamadaoka, Suita, Osaka, Japan
Tel
0668792278
nohara@dent.osaka-u.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 | 12 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
23
Results
We examined the effects of different types of thickening agents and viscosities of thickened water samples on the mucociliary transport function. The results revealed that the thickened water samples with high viscosity may take longer to be discharged via the mucociliary transport function, while there is no difference in the time of discharge between the thickened water samples with different types of thickening agents.
Results date posted
| 2021 | Year | 12 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
saccharine time
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 10 | Day |
Date analysis concluded
| 2021 | Year | 10 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 21 | Day |
Last modified on
| 2021 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052973
