NCT03229551

Xylitol for Chronic Sinusitis

Xylitol Topical Irrigation for Treatment of Recalcitrant Chronic Sinusitis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Ochsner Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Rhinosinusitis
• Rhinosinusitis
• Sinusitis
• Drain Sinus
• Endoscopic Sinus Surgery
• Biofilms
• Bacterial Overgrowth

Interventions

Type	Name	Description
DRUG	Xylitol	Topical 5% Xylitol (wt/vol) diluted in saline nasal irrigant. Topical corticosteroid and antibiotic as directed by bacterial DNA sequencing results will be diluted in this irrigant and administered concurrently.
DRUG	Saline	Saline as a standard-of-care nasal irrigant. Topical corticosteroid and antibiotic as directed by bacterial DNA sequencing results will be diluted in this irrigant and administered concurrently.

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-07-16
• Completion: 2018-07-16
• First posted: 2017-07-25
• Last updated: 2023-04-07

Locations

1 site across 1 country: United States