None listed
Conditions
Brief summary
The presence of biofilms within the paranasal sinuses have been correlated to poorer clinical outcomes following treatment for chronic rhinosinusitis. In light of the resistance of biofilm bacteria to conventional antibiotics, a number of novel approaches for treating biofilms have been proposed, including physical removal of the biofim by irrigation, interfering with chemical communication between micro-organisms or degrading the biofilm matrix with enzymes. The effect of Xylitol on the microbiome of CRS has not yet been evaluated. It is hypothesised that xylitol may be an effective method for reducing biofilms and improving outcomes in CRS. If Xylitol nasal irrigation can reduce the bacterial burden within CRS sinuses, this simple, safe and effective treatment would be an invaluable, non-antibiotic addition to the treatment options for CRS.
Interventions
Pilot RCT - Thirty patients with a diagnosis of chronic rhinosinusitis (CRS) and attending a specialist rhinology clinic, will be recruited into this study.
Microbiological swabs will be taken from suitably recruited CRS patients for bacterial culture and microbacterial analysis. Nasal swabs will be performed under endoscopic guidance after application of local anaesthesia spray.
Patients will be randomised to receive either saline or xylitol nasal rinse.
Arm1
Patients randomised to receive
Pilot RCT - Thirty patients with a diagnosis of chronic rhinosinusitis (CRS) and attending a specialist rhinology clinic, will be recruited into this study. Microbiological swabs will be taken from suitably recruited CRS patients for bacterial culture and microbacterial analysis. Nasal swabs will be performed under endoscopic guidance after application of local anaesthesia spray. Patients will be randomised to receive either saline or xylitol nasal rinse. Arm1 Patients randomised to receive xylitol will be supplied with xylitol and given instructions to make a 4% solution which will be used three times daily for two weeks. Arm2 Patients in the saline group will be given instructions to make a physiological saline solution using sea salt, which will also be used three times daily for two weeks. At the end of that two week period, patients will return to the clinic for re-assessment where further swabs are taken. Monitoring of therapy will be by completion of a patient diary template.
Sponsors
Associate Professor Richard Douglas
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients diagnosed with chronic rhinosinusitis Patients providing full-informed consent to participate in this study
Exclusion criteria
1. Children (<16 years) 2. Cystic fibrosis 3. Immunodeficiency (congenital or acquired) 4. Congenital mucociliary problems (e.g. primary ciliary dyskinesia) 5. Non-invasive and invasive fungal sinus disease 6. Systemic vasculitis and granulomatous diseases 7. History of cocaine abuse; 8. Patients requiring sinus surgery for neoplasia 9. Patients unable to consent (e.g. lack of mental capacity)
Outcome results
None listed