The Sinonasal Microbiome

NCT06822725 | Active Not Recruiting DMC

• 1 other identifier: 09-354-A
• Study Type: observational
• Target: 285
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• the discovery of low frequency and novel organisms using the Pyrosequencing Pipeline service

  At baseline until final values at 36 months.

Study Arms (2)

Chronic rhinosinusitis (CRS) with and without Nasal Polyposis

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

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

Control Group

Normals without allergy, those with perennial allergic rhinitis

Other: Control Group

Interventions

Control Group OTHER

normals without allergy, those with perennial allergic rhinitis

Control Group

Chronic rhinosinusitis (CRS) with and without Nasal Polyposis PROCEDURE

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

Chronic rhinosinusitis (CRS) with and without Nasal Polyposis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will examine the sinonasal microbiota in subjects with CRS (at baseline in those with and without nasal polyps, and those with acute exacerbations) and controls (normals without allergy, those with perennial allergic rhinitis).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Hyde Park, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jayat Pinto, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 12, 2025
• Study Start: January 13, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (1)