Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis (CRS): A Randomized, Placebo Controlled Cross Over Trial

What this Trial Is About

Chronic rhinosinusitis (CRS) is a condition that negatively affects quality of life and carries significant societal costs. The cause of CRS is not fully understood, and current treatments are based on observed effects rather than a clear understanding of the disease mechanisms. CRS is divided into types based on the presence of nasal polyps, and recent research suggests that differences in the inflammatory profile, or endotype, are important for studying the disease. This trial explores the role of the nasal microbiome in CRS, following previous findings that microbiome transplants may reduce symptoms in patients without nasal polyps. Participants in this study will receive 13 days of antibiotics followed by either five consecutive days of a sinonasal microbiome transplant from a healthy donor or five days of a placebo saline transplant administered as nasal lavage. The study uses a double-blind, placebo-controlled, crossover design to compare these treatments. The transplant aims to restore a healthy nasal microbiome, and the study will analyze differences in microbiome structure, stability, and function between CRS patients and healthy donors. During the study, participants will be evaluated before and after the interventions using several assessments including the Sino-Nasal Outcome Test 22 (SNOT-22), endoscopy, nasal symptom scores, and analyses of microbiome and inflammatory markers. These evaluations will take place at multiple time points up to three years after the study to monitor symptom changes, microbiome effects, and safety. The total study duration is one year and five months, with an additional three years of follow-up for long-term outcomes.

Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis (CRS).