A randomized, double-blind, placebo-controlled study to investigate the use of bacteriophages in patients with chronic rhinosinusitis with nasal polyps

Introduction: A randomized, double-blind, placebo-controlled study investigates the use of bacteriophages in the treatment of chronic rhinosinusitis with nasal polyps. Material and methods: 40 adult patients with chronic rhinosinusitis with nasal polyps were examined. All patients underwent functional endoscopic sinus surgery. After the surgery, 20 patients were administered an intranasal gel with bacteriophage mixture (Otofag, Micromir, Russia) twice a day for ten weeks, while 20 other patients received a placebo solution. Results: On the 10th day, IL-1β secretion diminished (63 mg/ml versus 440 mg/ml in control). There was a decrease in the total number of microorganisms and Enterobacteriaceae (5.7 x 10⁶ CFU/ml versus 1.2 x 10⁹ CFU/ml in the control group) and the absence of Streptococci (versus 2.1 x 10⁹ CFU/ml in control) was noted on the 30th day of treatment in the group receiving bacteriophage mixture. On the 10th day, a decrease in the activity of secretory IL-1β and IL-8 strongly and very strongly correlated with a total number of microorganisms (r = 0.7; r = 0.9, respectively), as well as a decrease in the activity of secretory IL-8 correlated with the number of Enterobacteriaceae (r = 0.72) and Staphylococci (r = 0.65) in the experimental group treated with bacteriophages. On the 30th day, the decrease in serum IL-1β significantly correlated with the total number of microorganisms (r = 0.80) and Enterobacteriaceae (r = 0.90) in the experimental group. Conclusions: The administration of bacteriophages restored the balance of microorganisms in the nasal cavity and decreased inflammatory response in chronic rhinosinusitis with nasal polyps. Changes such as an inflammation dampening could potentially contribute to reducing recurrent growth of polyp tissue in the future.