Project 461777
SinoNasal Microbiota Transfer (SNMT) to treat chronic rhinosinusitis: A randomized, double-blind, placebo-controlled trial
SinoNasal Microbiota Transfer (SNMT) to treat chronic rhinosinusitis: A randomized, double-blind, placebo-controlled trial
Project Information
| Study Type: | Unclear |
| Research Theme: | Clinical |
Institution & Funding
| Principal Investigator(s): | Manges, Amee R; Javer, Amin R |
| Co-Investigator(s): | Singer, Joel; Thamboo, Andrew |
| Institution: | University of British Columbia |
| CIHR Institute: | Infection and Immunity |
| Program: | |
| Peer Review Committee: | Clinical Investigation - B 2 |
| Competition Year: | 2022 |
| Term: | 5 yrs 0 mth |
Abstract Summary
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 us 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, our 'snot transplant' 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. We 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 within 45 days compared to a sinus power wash and sham SNMT. We will investigate the safety profile of SNMT and determine if SNMT-related CRS symptom improvement lasts up to 6 months. Finally, we will investigate how SNMT contributes to CRS recovery, by tracking changes in the sinus microbiota and inflammation pre- and post-treatment. Results from our pilot study shows that SNMT produced CRS symptom improvement in 75% of patients. SNMT therapy may be a transformative strategy to address CRS, a chronic and debilitating illness.
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