The Sinonasal Microbiome

Active, not recruiting

• Conditions: Sinonasal Disorder; Chronic Rhinosinusitis (Diagnosis)

• Registration Number: NCT06822725
• Lead Sponsor: University of Chicago

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-13
• Study First Submitted: 2025-01-28
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Primary Completion: 2029-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 285

Inclusion Criteria

• Age>18 years
• Diagnosis of chronic sinusitis (with or without nasal polyposis), perennial allergic rhinitis, or normal sinuses/absence of allergy

Exclusion Criteria

• Use of immunosuppressants
• Immunodeficiency
• Inability to stop sinusitis related medications for 10 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determining the distinct bacterial profiles with abundance of organisms using the Pyrosequencing Pipeline service	At baseline until final values at 36 months.
Determining the distinct bacterial profiles with shift toward anaerobic bacteria using the Pyrosequencing Pipeline service	At baseline until final values at 36 months.
Determining the distinct bacterial profiles with lower bacterial diversity using the Pyrosequencing Pipeline service	At baseline until final values at 36 months.

Secondary Outcome Measures

Name	Time	Method
the discovery of low frequency and novel organisms using the Pyrosequencing Pipeline service	At baseline until final values at 36 months.

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Hyde Park, Illinois, United States