Xylitol for Chronic Sinusitis

Phase 2

Completed

• Conditions: Drain Sinus; Chronic Rhinosinusitis; Rhinosinusitis; Sinusitis; Endoscopic Sinus Surgery; Biofilms; Bacterial Overgrowth
• Interventions: Drug: Saline; Drug: Xylitol

• Registration Number: NCT03229551
• Lead Sponsor: Ochsner Health System

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.

Study Timeline

• Study First Submitted: 2017-07-21
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-25
• Study Start: 2018-03-01
• Primary Completion: 2018-07-16
• Study Completion: 2018-07-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Saline	This arm is the standard of care saline irrigation solution.
Xylitol	Xylitol	This arm will evaluate the effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention.

Primary Outcome Measures

Name	Time	Method
The effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention.	3 months	Bacterial DNA sequencing obtained via endoscopic swab will be performed pre-treatment to analyse the presence of biofims in the diseased sinus. This assay will be repeated from the same sinus post-treatment with 5% Xylitol (wt/vol) to evaluate if medical intervention decreases biofilm production in the diseased sinus.

Secondary Outcome Measures

Name	Time	Method
Brief Smell Identification Test (BSIT)	3 months	Total scores range from 0 to 12; higher scores indicate greater olfactory function
Sino-Nasal Outcome Test-22 (SNOT-22)	3 months	Maximum score of 110 points based on responses to 22 questions
Endoscopic appearance of the patient's sinuses in response to the use of topical xylitol	3 months
Correlation of DNA seqeuncing results with conventional sinonasal cultures	3 months

Trial Locations

Locations (1)

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States