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OpenTrials
Active, Not Recruiting

NCT Number: NCT06822725

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Chicago

Hyde Park, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Group

Other

normals without allergy, those with perennial allergic rhinitis

Chronic rhinosinusitis (CRS) with and without Nasal Polyposis

Procedure

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

Primary outcomes

  1. Determining the distinct bacterial profiles with abundance of organisms using the Pyrosequencing Pipeline service

    Time frame: At baseline until final values at 36 months.

  2. Determining the distinct bacterial profiles with shift toward anaerobic bacteria using the Pyrosequencing Pipeline service

    Time frame: At baseline until final values at 36 months.

  3. Determining the distinct bacterial profiles with lower bacterial diversity using the Pyrosequencing Pipeline service

    Time frame: At baseline until final values at 36 months.

Secondary outcomes

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

    Time frame: At baseline until final values at 36 months.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Feb 12, 2025
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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