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Microbiota Transfer for Chronic Rhinosinusitis

Study acronym: SNMT
StatusActive, Not Recruiting
PhaseNot applicable
SponsorAmin Javer
Started
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Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Jun 2024 to Apr 14, 2024
    • Study completion date: Jun 2025 to Jun 2026
    • Site details revised
    v3
  2. Notable Primary endpoint revised
    • Secondary endpoints: 4 to 5
    • Study description expanded, about 3 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Chronic sinusitis (CRS) is a common inflammatory condition of the sinuses that affects up to 2.5% of the Canadian population, and is thought to be caused by bacterial infection, resistant biofilms, chronic inflammation and possibly an unhealthy population of sinus microbes (or microbiota). Symptoms include nasal obstruction and discharge, facial pain, loss of smell and sleep disturbance, which all strongly impact quality of life. CRS treatment involves nasal or oral steroids, repeated rounds of antibiotic, and sinus surgery. Despite maximal treatment, some recalcitrant patients suffer with CRS for years. The lack of new, effective therapies to treat CRS leads the investigators to test whether a SinoNasal Microbiota Transfer (SNMT) could trigger CRS recovery. SNMT is defined as the endoscopic transfer of a healthy sinus microbiota from a fully screened donor's sinus to a CRS patient's sinus(es). Similar to a fecal transplant used to treat Clostridioides difficile diarrhea, the sinonasal microbiota transfer may eliminate sinus pathogens and restore the sinus microbiota to a healthy state. SNMT will be combined with a one-time, high volume, high pressure "sinus power wash" pre-treatment to temporarily clear the way for the donor microbiota to establish itself. The investigators will conduct a proof-of-principle, randomized, double-blind, placebo-controlled trial of 80 subjects to test whether a sinus power wash plus SNMT improves clinical outcomes in CRS patients.
Trial Details
NCT Number NCT05454072
Lead Sponsor Amin Javer
Conditions
(from sponsor)
Sinusitis, Chronic, Sinus Disease, Sinus Infection, Sinus Infection Chronic
Related terms Bronchiolitis Obliterans Syndrome, Paranasal Sinus Diseases, Sinusitis
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov