UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063134 |
|---|---|
| Receipt number | R000072268 |
| Scientific Title | An Exploratory Study on the Relationship Between Abnormal Airway Ciliary Movement and the Oral Microbiome |
| Date of disclosure of the study information | 2026/10/02 |
| Last modified on | 2026/10/01 20:11:21 |
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Basic information
Public title
An Exploratory Study on the Relationship Between Abnormal Airway Ciliary Movement and the Oral Microbiome
Acronym
Research on Oral Bacteria and Flagellar Motility
Scientific Title
An Exploratory Study on the Relationship Between Abnormal Airway Ciliary Movement and the Oral Microbiome
Scientific Title:Acronym
An Exploratory Study on the Effects of the Oral Microbiome on Airway Ciliary Motility
Region
| Japan |
Condition
Condition
Pneumonia in the Elderly
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to quantitatively assess airway ciliary motility using human nasal mucosal swab samples and, by integrating these findings with NGS-based analysis of the oral microbiome, serum (plasma) analysis, and peripheral blood mononuclear cell (PBMC) analysis, to exploratively elucidate the association between the oral microbiome and ciliary motility abnormalities, as well as the association between the oral microbiome and aspiration pneumonia.
Basic objectives2
Others
Basic objectives -Others
Study Reveals Characteristics of Oral Microbial Flora Profiles and Reduced Ciliary Motility Associated with Aspiration Pneumonia
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We will examine the relationship between the microbial community indices obtained from NGS analysis of tongue swab samples and the ciliary motility indices (CBF, ciliary motility amplitude, ciliary motility coordination, percentage of non-motile cilia, microbead migration velocity, etc.) obtained from nasal mucosal scraping samples.
Key secondary outcomes
Associations between serum cytokines and chemokines, PBMC immune cell profiles, and the tongue microbiota, ciliary motility indices, and aspiration pneumonia.
Associations between exploratory microbiota patterns, including those of the genera Prevotella, Veillonella, Fusobacterium, and Rothia, and ciliary-related gene expression, inflammatory markers, and pneumonia severity and outcomes.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Group A: Healthy controls aged 59 or younger
Individuals with no history of active respiratory infections, rhinosinusitis, oral infections, chronic respiratory diseases, malignant tumors, or immunodeficiency, as determined by self-report and medical history.
Group B: Elderly patients aged 60 years or older with no history of aspiration pneumonia
Individuals with no active pneumonia at the time of obtaining informed consent and no history of aspiration pneumonia documented in their medical records.
Group C: Patients aged 60 years or older hospitalized for bacterial pneumonia
Individuals requiring hospitalization for treatment based on a diagnosis of bacterial pneumonia.
Key exclusion criteria
Patients with a history of stroke sequelae, neurological disorders, intracranial diseases, or other conditions that raise suspicion of overt dysphagia.
Patients receiving long-term, low-dose macrolide therapy for chronic lower respiratory tract infections or long-term administration of ST combination therapy for prophylactic purposes.
Individuals who have been using steroids or immunosuppressants for an extended period.
Individuals at high risk of pneumonia caused by other pathogens such as mycobacteria, fungi, or viruses; exacerbation of interstitial pneumonia; or obstructive pneumonia (interstitial pneumonia as an underlying condition is not excluded).
Individuals for whom nasal swab collection is deemed inappropriate due to active epistaxis, severe nasal obstruction, nasal tumors, recent nasal or paranasal sinus surgery, or severe rhinosinusitis.
Individuals deemed to be at high risk for nasal mucosal scraping or blood collection due to thrombocytopenia, coagulation disorders, or an increased risk of bleeding while on anticoagulant therapy.
Individuals who have used systemic antibiotics within the past 3 months, or those in Groups A and B who have an active infection.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Iwanaga |
Organization
Nagasaki University Hospital
Division name
Department of Respiratory Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City
TEL
0958197273
niwanaga@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Iwanaga |
Organization
Nagasaki University Hospital
Division name
Department of Respiratory Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City
TEL
0958197273
Homepage URL
niwanaga@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Naoki Iwanaga
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
Nagasaki University Hospital
Address
1-7-1, Sakamoto Nagasaki City
Tel
0958197273
niwanaga@nagasaki-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
| 2026 | Year | 10 | Month | 02 | 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
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ciliary motion analysis will be performed on nasal mucosal scrapings using a high-speed camera or ciliary motion analysis software.
In addition, bacterial flora will be analyzed in tongue swab samples via 16S rRNA gene amplicon sequencing or equivalent NGS following DNA extraction.
For Group B (elderly individuals who have not developed pneumonia) and Group C (elderly individuals with pneumonia), serum and PBMCs will be collected and stored for the measurement of inflammatory cytokines, chemokines, and other markers.
Management information
Registered date
| 2026 | Year | 10 | Month | 01 | Day |
Last modified on
| 2026 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072268
