Clinical trial NCT06822725: The Sinonasal Microbiome
Official title: The Sinonasal Microbiome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sinonasal Disorder
Chronic Rhinosinusitis (Diagnosis)
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.


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

Primary outcomes:
measure: Determining the distinct bacterial profiles with abundance of organisms using the Pyrosequencing Pipeline service
timeFrame: At baseline until final values at 36 months.
measure: Determining the distinct bacterial profiles with shift toward anaerobic bacteria using the Pyrosequencing Pipeline service
timeFrame: At baseline until final values at 36 months.
measure: Determining the distinct bacterial profiles with lower bacterial diversity using the Pyrosequencing Pipeline service
timeFrame: At baseline until final values at 36 months.
Secondary outcomes:
measure: the discovery of low frequency and novel organisms using the Pyrosequencing Pipeline service
timeFrame: At baseline until final values at 36 months.
Other outcomes:
Locations:
city: Hyde Park
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jayat Pinto, MD
role: PRINCIPAL_INVESTIGATOR
References: