RecruitingACTRN12615000154505

The Effect of Xylitol and Saline Nasal Irrigations on the Sinus Microbiome in Patients with Chronic Rhinosinusitis

The effect of xylitol and saline nasal irrigations on the microbiome of patients with chronic sinusitis, a study by the Department of Surgery, University of Auckland.


Sponsor

Associate Professor Richard Douglas

Enrollment

30 participants

Start Date

Feb 16, 2015

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether xylitol — a natural sugar substitute — can be used as a nasal rinse to reduce bacterial buildup in the sinuses of people with chronic rhinosinusitis (long-term sinus inflammation). Current antibiotics often struggle to clear the bacteria that form protective layers (biofilms) inside the sinuses. Xylitol may help break down these layers without antibiotics. You may be eligible if: - You are 16 years of age or older - You have been diagnosed with chronic rhinosinusitis - You are willing and able to give informed consent You may NOT be eligible if: - You have cystic fibrosis - You have a weakened immune system - You have a congenital problem with your cilia (the small hair-like structures in your airways) - You have fungal sinus disease - You have a systemic inflammatory or vascular condition - You have a history of cocaine abuse - You need sinus surgery for cancer - You are unable to consent due to mental incapacity Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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

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.


Locations(1)

New Zealand

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12615000154505


Related Trials