The Sinonasal Microbiome

The University of Chicago

Status: Active, not recruiting

Conditions: Sinonasal Disorder; Chronic Rhinosinusitis (Diagnosis)

Treatments: Procedure: Chronic rhinosinusitis (CRS) with and without Nasal Polyposis; Other: Control Group

Study type: Observational

Funder types: Other

Identifiers

NCT06822725

09-354-A

Details and patient eligibility

About

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.

Enrollment: 285 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

285 participants in 2 patient groups

Chronic rhinosinusitis (CRS) with and without Nasal Polyposis

Description:

Those with and without nasal polyps, and those with acute exacerbations

Treatment:

Procedure: Chronic rhinosinusitis (CRS) with and without Nasal Polyposis

Control Group

Description:

Normals without allergy, those with perennial allergic rhinitis

Treatment:

Other: Control Group