The Sinonasal Microbiome

NCT ID: NCT06822725

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 285 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-13
• Study Completion Date: 2029-01-31

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.

Conditions

Sinonasal Disorder; Chronic Rhinosinusitis (Diagnosis)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic rhinosinusitis (CRS) with and without Nasal Polyposis

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

Chronic rhinosinusitis (CRS) with and without Nasal Polyposis

Intervention Type: PROCEDURE

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

Control Group

Normals without allergy, those with perennial allergic rhinitis

Control Group

Intervention Type: OTHER

normals without allergy, those with perennial allergic rhinitis

Interventions

Control Group

normals without allergy, those with perennial allergic rhinitis

Intervention Type: OTHER

Chronic rhinosinusitis (CRS) with and without Nasal Polyposis

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jayat Pinto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The University of Chicago

Hyde Park, Illinois, United States

Countries

United States

Other Identifiers

09-354-A

Identifier Type: -

Identifier Source: org_study_id