The Sinonasal Microbiome

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Rhinosinusitis (Diagnosis); Sinonasal Disorder
• Intervention / Treatment: Procedure: Chronic rhinosinusitis (CRS) with and without Nasal Polyposis; Other: Control Group

• Study Type: Observational
• Enrollment (Estimated): 285

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Hyde Park, Illinois, United States, 60637
      • The University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Those with and without nasal polyps, and those with acute exacerbations
Control Group; Normals without allergy, those with perennial allergic rhinitis	Other: Control Group; normals without allergy, those with perennial allergic rhinitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Jayat Pinto, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 09-354-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No