NCT06822725

The Sinonasal Microbiome

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 285 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Chronic rhinosinusitis is an inflammatory disease of the sinonasal mucosa with significant impact and limited treatment options. Chronic rhinosinusitis (CRS) poses an important public health problem and causes a large impact on individual quality of life. Studies of CRS have been limited by access to tissue, the complexity of the sinonasal physiology, a lack of available biomarkers, the absence of useful animal models, a paucity of cohorts with biological samples for analysis, and limited well-designed clinical trials or investigations of immune function. Therefore, novel strategies for identifying biological mechanisms underlying this disease are in great need. Using prospective samples from well characterized subjects, the investigators intend to profile the mucosa associated-bacteria in the nose and sinuses. In parallel, using sinus tissue from patients undergoing surgery, the site will interrogate the epithelium for mucosal immune function to understand host-microbe interaction. This study hypothesizes that the microbial profile of the sinuses initiates an immune responses which leads to chronic inflammation in susceptible people. This study would provide the first comprehensive data on what bacteria are present in the nose and sinus and could lead to important knowledge useful in sinonasal disease.

Conditions

• Sinonasal Disorder
• Chronic Rhinosinusitis (Diagnosis)

Interventions

Type	Name	Description
OTHER	Control Group	normals without allergy, those with perennial allergic rhinitis
PROCEDURE	Chronic rhinosinusitis (CRS) with and without Nasal Polyposis	Those with and without nasal polyps, and those with acute exacerbations

Timeline

• Start date: 2025-01-13
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2025-02-12
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States