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Completed

NCT Number: NCT03229551

Xylitol for Chronic Sinusitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xylitol

Drug

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.

Saline

Drug

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.

Primary outcomes

  1. The effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention.

    Time frame: 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 outcomes

  1. Sino-Nasal Outcome Test-22 (SNOT-22)

    Time frame: 3 months

    Maximum score of 110 points based on responses to 22 questions

  2. Brief Smell Identification Test (BSIT)

    Time frame: 3 months

    Total scores range from 0 to 12; higher scores indicate greater olfactory function

  3. Endoscopic appearance of the patient's sinuses in response to the use of topical xylitol

    Time frame: 3 months

  4. Correlation of DNA seqeuncing results with conventional sinonasal cultures

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Ochsner Health System

Other

Collaborators

  • Tulane University School of Medicine

Registry information

Official study title

Xylitol Topical Irrigation for Treatment of Recalcitrant Chronic Sinusitis

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 25, 2017
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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