Sinonasal DisorderNCT06822725
The Sinonasal Microbiome
An observational study of Sinonasal Disorder and Chronic Rhinosinusitis (Diagnosis), run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sinonasal Disorder, Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Chronic rhinosinusitis (CRS) with and without Nasal Polyposis
- Type of treatment
- Surgery or procedure
- How many people
- 285 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Age>18 years
- Diagnosis of chronic sinusitis (with or without nasal polyposis), perennial allergic rhinitis, or normal sinuses/absence of allergy
Who cannot join
- Use of immunosuppressants
- Immunodeficiency
- Inability to stop sinusitis related medications for 10 days
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago
Hyde Park, Illinois, 60637
About this study
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.
- Being tested
- Control Group, Chronic rhinosinusitis (CRS) with and without Nasal Polyposis
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
normals without allergy, those with perennial allergic rhinitis
Chronic rhinosinusitis (CRS) with and without Nasal PolyposisProcedure or surgery
Those with and without nasal polyps, and those with acute exacerbations
| Study group | Role | What they receive |
|---|---|---|
| Chronic rhinosinusitis (CRS) with and without Nasal Polyposis | Those with and without nasal polyps, and those with acute exacerbations Receives: Procedure: Chronic rhinosinusitis (CRS) with and without Nasal Polyposis | |
| Control Group | Normals without allergy, those with perennial allergic rhinitis Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the distinct bacterial profiles with abundance of organisms using the Pyrosequencing Pipeline service
Measured: At baseline until final values at 36 months.
Determining the distinct bacterial profiles with shift toward anaerobic bacteria using the Pyrosequencing Pipeline service
Measured: At baseline until final values at 36 months.
Determining the distinct bacterial profiles with lower bacterial diversity using the Pyrosequencing Pipeline service
Measured: At baseline until final values at 36 months.
Secondary outcomes (1)
the discovery of low frequency and novel organisms using the Pyrosequencing Pipeline service
Measured: At baseline until final values at 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start13 Jan 2025
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinonasal DisorderStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayat Pinto, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822725
- Sponsor's protocol ID
- 09-354-A
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sinonasal Microbiome
- ClinicalTrials.gov ID
- NCT06822725
- Acronym / sponsor ID
- 09-354-A
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic rhinosinusitis (CRS) with and without Nasal Polyposis | – | Procedure: Chronic rhinosinusitis (CRS) with and without Nasal PolyposisThose with and without nasal polyps, and those with acute exacerbations |
| Control Group | – | Other: Control GroupNormals without allergy, those with perennial allergic rhinitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Age>18 years
- Diagnosis of chronic sinusitis (with or without nasal polyposis), perennial allergic rhinitis, or normal sinuses/absence of allergy
Key exclusion criteria (3 listed)
- Use of immunosuppressants
- Immunodeficiency
- Inability to stop sinusitis related medications for 10 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control Groupnormals without allergy, those with perennial allergic rhinitis | Other | Control Group |
| Chronic rhinosinusitis (CRS) with and without Nasal PolyposisThose with and without nasal polyps, and those with acute exacerbations | Procedure or surgery | Chronic rhinosinusitis (CRS) with and without Nasal Polyposis |
Primary outcome
Determining the distinct bacterial profiles with abundance of organisms using the Pyrosequencing Pipeline service
Time frame: At baseline until final values at 36 months.
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.
Determining the distinct bacterial profiles with lower bacterial diversity using the Pyrosequencing Pipeline service
Time frame: At baseline until final values at 36 months.
1 secondary outcome
the discovery of low frequency and novel organisms using the Pyrosequencing Pipeline service
Time frame: At baseline until final values at 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
Related trials for Sinonasal Disorder
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Nasal Neoplasm, Nasal Neoplasm Benign
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayat Pinto, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinonasal Disorder and Chronic Rhinosinusitis (Diagnosis), run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the distinct bacterial profiles with abundance of organisms using the Pyrosequencing Pipeline service (time frame: At baseline until final values at 36 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.