Tokyo, Oct. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063134) titled 'An Exploratory Study on the Relationship Between Abnormal Airway Ciliary Movement and the Oral Microbiome' on Oct. 2.

Study Type: Observational

Primary Sponsor: Institute - Nagasaki University Hospital

Condition: Condition - Pneumonia in the Elderly Classification by malignancy - Others Genomic information - NO

Objective: 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

Eligibility: Age-lower limit - 20 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 Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 01 Day Anticipated trial start date - 2026 Year 10 Month 19 Day Last follow-up date - 2029 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072268

Disclaimer: Curated by HT Syndication.