UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059628 |
|---|---|
| Receipt number | R000068199 |
| Scientific Title | Immunological Mechanisms of Chronic Nasopharyngitis and Therapeutic Effects of Epipharyngeal Abrasive Therapy (EAT) |
| Date of disclosure of the study information | 2025/11/04 |
| Last modified on | 2025/11/03 21:58:11 |
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Basic information
Public title
Study on the Therapeutic Effects of Epipharyngeal Abrasive Therapy (EAT) and Immune Profile Changes in Chronic Nasopharyngitis
Acronym
Chronic Nasopharyngitis and EAT Effects
Scientific Title
Immunological Mechanisms of Chronic Nasopharyngitis and Therapeutic Effects of Epipharyngeal Abrasive Therapy (EAT)
Scientific Title:Acronym
Immune Profiling and EAT Effects in Chronic Nasopharyngitis
Region
| Japan |
Condition
Condition
Chronic Nasopharyngitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively evaluate immune profile changes before and after Epipharyngeal Abrasive Therapy (EAT) in patients with chronic nasopharyngitis using flow cytometry of scraped epithelial cells and peripheral blood. The study also aims to identify disease-specific immune characteristics by comparing with healthy controls.
Basic objectives2
Others
Basic objectives -Others
This study aims to quantitatively assess immune profile changes in chronic nasopharyngitis and clarify the immunomodulatory effects of Epipharyngeal Abrasive Therapy (EAT).
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in CD4/CD8 ratio in scraped epithelial cells and peripheral blood before and after EAT (evaluated at baseline and 3 months after treatment)
Key secondary outcomes
Change in Th17/Treg ratio (baseline and 3 months)
Transition of subjective symptom scores (VAS) at baseline, 1 month, and 3 months
Change in endoscopic inflammatory findings (baseline and 3 months)
Comparison of immune profiles with healthy controls
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with chronic nasopharyngitis will receive Epipharyngeal Abrasive Therapy (EAT) once a week for 4 weeks. Peripheral blood and epipharyngeal swab samples will be collected before and after the intervention to evaluate changes in immune cell composition.
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants diagnosed with chronic nasopharyngitis, aged 15 years or older, who consent to EAT and understand the study purpose and provide written informed consent.
Key exclusion criteria
Individuals with severe systemic diseases, those using immunosuppressive agents, pregnant or breastfeeding women, or those deemed inappropriate by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Mogitate |
Organization
Mogitate Medical Corporation
Division name
Mogitate ENT Clinic
Zip code
2130011
Address
4F-401, Sekiguchi Daiichi Building, 1-2-5 Hisamoto, Takatsu-ku, Kawasaki-shi, Kanagawa, Japan
TEL
0448654187
mogitateentjp@m08.itscom.net
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Mogitate |
Organization
Mogitate Medical Corporation
Division name
Mogitate ENT Clinic
Zip code
2130011
Address
4F-401, Sekiguchi Daiichi Building, 1-2-5 Hisamoto, Takatsu-ku, Kawasaki-shi, Kanagawa, Japan
TEL
0448654187
Homepage URL
mogitateentjp@m08.itscom.net
Sponsor or person
Institute
Mogitate Medical Corporation
Institute
Department
Personal name
Manabu Mogitate
Funding Source
Organization
Mogitate Medical Corporation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Manabu Mogitate
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board: Ota General Hospital Ethics Committee
Address
1-50 Nisshin-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
Tel
0442440131
info@ota-g-hospital.com
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
| 2025 | Year | 11 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 03 | Day |
Last modified on
| 2025 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068199
