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Xylitol for Chronic Sinusitis

This study is not yet open for participant recruitment.
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Verified July 2017 by Edward Mccoul, MD, Ochsner Health System
Sponsor:
Information provided by (Responsible Party):
Edward Mccoul, MD, Ochsner Health System
ClinicalTrials.gov Identifier:
NCT03229551
First received: July 21, 2017
Last updated: July 24, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention Phase
Chronic Rhinosinusitis Drug: Xylitol Drug: Saline Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Xylitol Topical Irrigation for Treatment of Recalcitrant Chronic Sinusitis

Resource links provided by NLM:


Further study details as provided by Edward Mccoul, MD, Ochsner Health System:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Sino-Nasal Outcome Test-22 (SNOT-22) [ Time Frame: 3 months ]
    Maximum score of 110 points based on responses to 22 questions

  • Brief Smell Identification Test (BSIT) [ Time Frame: 3 months ]
    Total scores range from 0 to 12; higher scores indicate greater olfactory function

  • Endoscopic appearance of the patient's sinuses in response to the use of topical xylitol [ Time Frame: 3 months ]
  • Correlation of DNA seqeuncing results with conventional sinonasal cultures [ Time Frame: 3 months ]

Estimated Enrollment: 40
Anticipated Study Start Date: October 1, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: September 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Active Comparator: Control
This arm is the standard of care saline irrigation solution.
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03229551

Contacts
Contact: Edward McCoul, MD, MPH 5048424080 edward.mccoul@ochsner.org
Contact: Azad Hussain, MPH 5048426011 azad.hussain@ochsner.org

Sponsors and Collaborators
Ochsner Health System
  More Information

Responsible Party: Edward Mccoul, MD, Physician, Ochsner Health System
ClinicalTrials.gov Identifier: NCT03229551     History of Changes
Other Study ID Numbers: 2017.317
Study First Received: July 21, 2017
Last Updated: July 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be presented in either a paper or electronic format. Upon its arrival, it will immediately be de-identified. If presented in a paper format, it will immediately be transferred into an electronic database. Only key personnel will have access to this data. The data will be encrypted and stored on permanent hardware or within the Ochsner secure network on a password-protected workstation.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 21, 2017