Could a 'Sinus poop Transplant' cure chronic sinusitis? new trial says maybe.
NCT ID NCT05454072
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment for chronic sinusitis, a long-lasting sinus infection that doesn't get better with standard care. Researchers will take healthy bacteria from a donor's sinuses and transfer them into the sinuses of 80 patients, after a special sinus wash. The goal is to see if this can restore a healthy bacterial balance and improve symptoms like pain, congestion, and loss of smell.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2022
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for Patients: * Recalcitrant CRS patients * Able to provide informed consent * Diagnosed with CRS (with/without polyps) and have previously undergone functional endoscopic sinus surgery (Post-FESS) * Continued to fail despite receiving "maximal and adequate medical treatment" This is defined as patients who: * Have received topical nasal steroids in any form (Spray/ Rinse/ Atomized) for at least 3 months or at least one course of oral corticosteroids treatment (\>0.5 mg/kg for 2 weeks tapering dose); * Had at least one course of antibiotic treatment either based on culture and sensitivity of nasal sinus secretions or as long-term low dose macrolide therapy (clarithromycin 500mg twice a day for 2 weeks then 250 mg once a day for 4 weeks) for at least one trial or have received a course of itraconazole 100mg twice daily for 6 weeks * Have deteriorating SNOT-22 Scores (≥20) or do not improve after surgery and appropriate maximal medical management (MLK score ≥ 2, with at least 2 points on the discharge subdomain) Exclusion Criteria for Patients: * Diagnosed with sinonasal tumors * Autoimmune diseases affecting the upper airway (e.g., systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis) * Immune-compromised patients * Impairment in mucociliary function (e.g., cystic fibrosis, Kartagener syndrome) * Pregnant or planning to become pregnant or breastfeeding * Severe underlying disease with anticipated survival less than 6 months * Unable to tolerate SNMT for any reason Inclusion Criteria for Donors: * 19 years of age or older * Able to provide informed consent, complete donor screening, and adhere to SNMT mucus collection and testing procedures Exclusion Criteria for Donors: * If they are positive for any of the following: (i) from blood or mucus testing, human Immunodeficiency virus (HIV) I/II, hepatitis A IgM, hepatitis B surface antigen (HBsAg), hepatitis C, human T- lymphotropic virus (HTLV) I/II, methicillin-resistant Staphylococcus aureus, multidrug resistant bacteria, and/or SARS-CoV-2 * A history of sinonasal or lower airway disease within the last 2 years other than the common cold; diagnosed with CRS; diagnosed with acute rhinosinusitis within the last six months; asthma; and/or clinical findings of sinonasal disease at the inclusion visit and immunodeficiency; any history of active cancer, or risk factors for acquisition of HIV, syphilis, hepatitis A, hepatitis B, hepatitis C, prion, or relevant neurological disease, receipt of blood transfusion from a country other than Canada in the preceding 6 months, any type of antibiotic treatment or any systemic immunosuppressive agents in the 3 months prior to the donation, or any current or previous medical or psychosocial condition or behaviours, which in the opinion of the investigator, may pose a risk to the recipient or the donor
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
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Other studies related to the condition(s) this trial covers.
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