Xylitol for Chronic Sinusitis

Problem Statement:

The purpose of this investigation is to conduct a trial within a subgroup of
difficult-to-treat patients with CRS. This difficult group of patients will have undergone an
exhaustive surgical and medical treatment of CRS These patient often will be frustrated with
the lack of improvement in their symptoms despite maximal medical and surgical therapy. The
effectiveness of topical surfactants is a research gap in treating CRS but has promising
correlates in other medical fields.

Purpose of Study/Potential Impact:

The purpose of this investigation is to conduct a randomized controlled trial within a
subgroup of difficult-to-treat patients with CRS, evaluating the use of topical xylitol
treatment concurrently with topical steroid/antibiotics combination in the effort to disrupt
biofilms and improve disease control. The effectiveness of topical surfactants is a research
gap in treating CRS but has promising correlates in other medical fields.

Potential Benefits:

Topical xylitol could potentially decrease CRS symptoms, leading to improvements in patient
quality of life. This decrease could potentially lead to fewer visits to primary care
physicians/otolaryngologists. These could lead to less antibiotics, radiographs being
obtained and unnecessary surgical procedures being performed, all of which could potentially
reduce the burden of medical expenditure in the treatment of this disease.

Potential Risks:

Potential risks are minimal but include a sweet aftertaste in the mouth and burning in the
nose; which have been reported in previous studies.

Hypothesis:

5% (wt/vol) Xylitol saline irrigation into the diseased paranasal sinus, as a part of a
post-ESS refractory CRS management plan, will reduce biofilm formation in the sinus and
result in symptomatic relief in affected patients.

General Design:

A prospective, randomized, double-blinded experimental design will be utilized. Patients will
be randomized into the xylitol-saline treatment arm versus the control saline arm. Concurrent
corticosteroid/antibiotic therapy will be utilized in both arms based on results of bacterial
DNA sequencing. Patients will undergo weekly in-office irrigations for three weeks and will
be evaluated one month and three months post-treatment. The postoperative care will be
standardized across all participants.

Inclusion Criteria:

- Adult patients above the age of 18

- History of chronic rhinosinusitis history who had undergone bilateral endoscopic sinus
surgery to include at a minimum maxillary antrostomy and anterior ethmoidectomy.

- Continued chronic sinusitis that is refractory to medical therapy after surgical
intervention

Exclusion Criteria:

- Patients under age of 18

- Non-English speaking

- History of immunodeficiency disease

- Cystic fibrosis

- Primary ciliary dyskinesia

- History of granulomatous disease

- Active smoker

- Treatment with antifungal medications

- Use of antifungal medications

- Acute bacterial infection requiring antibiotics

- Active pregnancy