Clinical trial NCT03229551: Xylitol for Chronic Sinusitis
Official title: Xylitol Topical Irrigation for Treatment of Recalcitrant Chronic Sinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Rhinosinusitis
Rhinosinusitis
Sinusitis
Drain Sinus
Endoscopic Sinus Surgery
Biofilms
Bacterial Overgrowth
Keywords: chronic rhinosinusitis
chronically draining sinus
condemned sinus
post-endoscopic sinus surgery
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
Collaborators: name: Tulane University School of Medicine
First posted: 2017-07-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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. Specifically, the investigators will be studying the effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention.
timeFrame: 3 months
Secondary outcomes:
measure: Sino-Nasal Outcome Test-22 (SNOT-22)
timeFrame: 3 months
measure: Brief Smell Identification Test (BSIT)
timeFrame: 3 months
measure: Endoscopic appearance of the patient's sinuses in response to the use of topical xylitol
timeFrame: 3 months
measure: Correlation of DNA seqeuncing results with conventional sinonasal cultures
timeFrame: 3 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
Study officials:
References:
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