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SinoNasal Microbiota Transfer (SNMT) Trial to Treat Chronic Rhinosinusitis Underway
A clinical trial, “SinoNasal Microbiota Transfer (SNMT) to treat chronic rhinosinusitis: A randomized, double-blind, placebo-controlled trial,” is currently being conducted.
This trial is being run by Dr. Amin Javer at the St. Paul’s Sinus Centre and Dr. Amee Manges with UBC and the B.C. Centre for Disease Control. Other collaborators on this trial are Dr. Andrew Thamboo and Dr. Joel Singer.
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.
The SNMT intervention could be a new and advanced form of therapy for recalcitrant CRS (rCRC) patients. Current treatment methods, including multiple and prolonged rounds of antibiotics, have been largely unsuccessful. A proof-of-principle randomized, controlled trial is required to test the efficacy of SNMT therapy for rCRS. Microbiota-based interventions have been investigated in small observational studies, yet these often do not account for confounding by indication and are subject to other selection and ascertainment biases. Our project represents the first test of a microbiota-based, endoscopically-delivered intervention for rCRS.
We are currently recruiting patients for our trial with our clinical trials posting here.
Dr. Amin Javer