UMIN-CTR Clinical Trial

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
Email	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
Email	nohara@dent.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052973