<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03229551</url>
  </required_header>
  <id_info>
    <org_study_id>2017.317.B</org_study_id>
    <nct_id>NCT03229551</nct_id>
  </id_info>
  <brief_title>Xylitol for Chronic Sinusitis</brief_title>
  <official_title>Xylitol Topical Irrigation for Treatment of Recalcitrant Chronic Sinusitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ochsner Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tulane University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ochsner Health System</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this investigation is to conduct a randomized controlled trial within a&#xD;
      subgroup of difficult-to-treat patients with CRS, evaluating the use of topical xylitol&#xD;
      treatment concurrently with topical steroid/antibiotics combination in the effort to disrupt&#xD;
      biofilms and improve disease control. The effectiveness of topical surfactants is a research&#xD;
      gap in treating CRS but has promising correlates in other medical fields. Specifically, the&#xD;
      investigators will be studying the effect of topical xylitol therapy on biofilm production&#xD;
      with the use of PCR bacterial sequencing before and after medical intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Problem Statement:&#xD;
&#xD;
      The purpose of this investigation is to conduct a trial within a subgroup of&#xD;
      difficult-to-treat patients with CRS. This difficult group of patients will have undergone an&#xD;
      exhaustive surgical and medical treatment of CRS These patient often will be frustrated with&#xD;
      the lack of improvement in their symptoms despite maximal medical and surgical therapy. The&#xD;
      effectiveness of topical surfactants is a research gap in treating CRS but has promising&#xD;
      correlates in other medical fields.&#xD;
&#xD;
      Purpose of Study/Potential Impact:&#xD;
&#xD;
      The purpose of this investigation is to conduct a randomized controlled trial within a&#xD;
      subgroup of difficult-to-treat patients with CRS, evaluating the use of topical xylitol&#xD;
      treatment concurrently with topical steroid/antibiotics combination in the effort to disrupt&#xD;
      biofilms and improve disease control. The effectiveness of topical surfactants is a research&#xD;
      gap in treating CRS but has promising correlates in other medical fields.&#xD;
&#xD;
      Potential Benefits:&#xD;
&#xD;
      Topical xylitol could potentially decrease CRS symptoms, leading to improvements in patient&#xD;
      quality of life. This decrease could potentially lead to fewer visits to primary care&#xD;
      physicians/otolaryngologists. These could lead to less antibiotics, radiographs being&#xD;
      obtained and unnecessary surgical procedures being performed, all of which could potentially&#xD;
      reduce the burden of medical expenditure in the treatment of this disease.&#xD;
&#xD;
      Potential Risks:&#xD;
&#xD;
      Potential risks are minimal but include a sweet aftertaste in the mouth and burning in the&#xD;
      nose; which have been reported in previous studies.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      5% (wt/vol) Xylitol saline irrigation into the diseased paranasal sinus, as a part of a&#xD;
      post-ESS refractory CRS management plan, will reduce biofilm formation in the sinus and&#xD;
      result in symptomatic relief in affected patients.&#xD;
&#xD;
      General Design:&#xD;
&#xD;
      A prospective, randomized, double-blinded experimental design will be utilized. Patients will&#xD;
      be randomized into the xylitol-saline treatment arm versus the control saline arm. Concurrent&#xD;
      corticosteroid/antibiotic therapy will be utilized in both arms based on results of bacterial&#xD;
      DNA sequencing. Patients will undergo weekly in-office irrigations for three weeks and will&#xD;
      be evaluated one month and three months post-treatment. The postoperative care will be&#xD;
      standardized across all participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">July 16, 2018</completion_date>
  <primary_completion_date type="Actual">July 16, 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention.</measure>
    <time_frame>3 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sino-Nasal Outcome Test-22 (SNOT-22)</measure>
    <time_frame>3 months</time_frame>
    <description>Maximum score of 110 points based on responses to 22 questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Smell Identification Test (BSIT)</measure>
    <time_frame>3 months</time_frame>
    <description>Total scores range from 0 to 12; higher scores indicate greater olfactory function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endoscopic appearance of the patient's sinuses in response to the use of topical xylitol</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of DNA seqeuncing results with conventional sinonasal cultures</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Chronic Rhinosinusitis</condition>
  <condition>Rhinosinusitis</condition>
  <condition>Sinusitis</condition>
  <condition>Drain Sinus</condition>
  <condition>Endoscopic Sinus Surgery</condition>
  <condition>Biofilms</condition>
  <condition>Bacterial Overgrowth</condition>
  <arm_group>
    <arm_group_label>Xylitol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm is the standard of care saline irrigation solution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xylitol</intervention_name>
    <description>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.</description>
    <arm_group_label>Xylitol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>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.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients above the age of 18&#xD;
&#xD;
          -  History of chronic rhinosinusitis history who had undergone bilateral endoscopic sinus&#xD;
             surgery to include at a minimum maxillary antrostomy and anterior ethmoidectomy.&#xD;
&#xD;
          -  Continued chronic sinusitis that is refractory to medical therapy after surgical&#xD;
             intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under age of 18&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  History of immunodeficiency disease&#xD;
&#xD;
          -  Cystic fibrosis&#xD;
&#xD;
          -  Primary ciliary dyskinesia&#xD;
&#xD;
          -  History of granulomatous disease&#xD;
&#xD;
          -  Active smoker&#xD;
&#xD;
          -  Treatment with antifungal medications&#xD;
&#xD;
          -  Use of antifungal medications&#xD;
&#xD;
          -  Acute bacterial infection requiring antibiotics&#xD;
&#xD;
          -  Active pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ochsner Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Harvey RJ, Psaltis A, Schlosser RJ, Witterick IJ. Current concepts in topical therapy for chronic sinonasal disease. J Otolaryngol Head Neck Surg. 2010 Jun;39(3):217-31.</citation>
    <PMID>20470665</PMID>
  </reference>
  <reference>
    <citation>Al-Mutairi D, Kilty SJ. Bacterial biofilms and the pathophysiology of chronic rhinosinusitis. Curr Opin Allergy Clin Immunol. 2011 Feb;11(1):18-23. doi: 10.1097/ACI.0b013e3283423376.</citation>
    <PMID>21150431</PMID>
  </reference>
  <reference>
    <citation>Hoggard M, Wagner Mackenzie B, Jain R, Taylor MW, Biswas K, Douglas RG. Chronic Rhinosinusitis and the Evolving Understanding of Microbial Ecology in Chronic Inflammatory Mucosal Disease. Clin Microbiol Rev. 2017 Jan;30(1):321-348. doi: 10.1128/CMR.00060-16.</citation>
    <PMID>27903594</PMID>
  </reference>
  <reference>
    <citation>Rosen PL, Palmer JN, O'Malley BW Jr, Cohen NA. Surfactants in the management of rhinopathologies. Am J Rhinol Allergy. 2013 May-Jun;27(3):177-80. doi: 10.2500/ajra.2013.27.3873.</citation>
    <PMID>23710951</PMID>
  </reference>
  <reference>
    <citation>Riley P, Moore D, Ahmed F, Sharif MO, Worthington HV. Xylitol-containing products for preventing dental caries in children and adults. Cochrane Database Syst Rev. 2015 Mar 26;2015(3):CD010743. doi: 10.1002/14651858.CD010743.pub2.</citation>
    <PMID>25809586</PMID>
  </reference>
  <reference>
    <citation>Sakallioglu O, Guvenc IA, Cingi C. Xylitol and its usage in ENT practice. J Laryngol Otol. 2014 Jul;128(7):580-5. doi: 10.1017/S0022215114001340. Epub 2014 Jul 7.</citation>
    <PMID>24999540</PMID>
  </reference>
  <results_reference>
    <citation>Shashy RG, Moore EJ, Weaver A. Prevalence of the chronic sinusitis diagnosis in Olmsted County, Minnesota. Arch Otolaryngol Head Neck Surg. 2004 Mar;130(3):320-3. doi: 10.1001/archotol.130.3.320.</citation>
    <PMID>15023840</PMID>
  </results_reference>
  <results_reference>
    <citation>Cryer J, Schipor I, Perloff JR, Palmer JN. Evidence of bacterial biofilms in human chronic sinusitis. ORL J Otorhinolaryngol Relat Spec. 2004;66(3):155-8. doi: 10.1159/000079994.</citation>
    <PMID>15316237</PMID>
  </results_reference>
  <results_reference>
    <citation>Antunes MB, Feldman MD, Cohen NA, Chiu AG. Dose-dependent effects of topical tobramycin in an animal model of Pseudomonas sinusitis. Am J Rhinol. 2007 Jul-Aug;21(4):423-7. doi: 10.2500/ajr.2007.21.3046.</citation>
    <PMID>17882910</PMID>
  </results_reference>
  <results_reference>
    <citation>Chiu AG, Antunes MB, Palmer JN, Cohen NA. Evaluation of the in vivo efficacy of topical tobramycin against Pseudomonas sinonasal biofilms. J Antimicrob Chemother. 2007 Jun;59(6):1130-4. doi: 10.1093/jac/dkm087. Epub 2007 Apr 3.</citation>
    <PMID>17405780</PMID>
  </results_reference>
  <results_reference>
    <citation>Brown CL, Graham SM, Cable BB, Ozer EA, Taft PJ, Zabner J. Xylitol enhances bacterial killing in the rabbit maxillary sinus. Laryngoscope. 2004 Nov;114(11):2021-4. doi: 10.1097/01.mlg.0000147939.90249.47.</citation>
    <PMID>15510034</PMID>
  </results_reference>
  <results_reference>
    <citation>Cain RB, Lal D. Update on the management of chronic rhinosinusitis. Infect Drug Resist. 2013;6:1-14. doi: 10.2147/IDR.S26134. Epub 2013 Jan 23.</citation>
    <PMID>23378777</PMID>
  </results_reference>
  <results_reference>
    <citation>Lin L, Tang X, Wei J, Dai F, Sun G. Xylitol nasal irrigation in the treatment of chronic rhinosinusitis. Am J Otolaryngol. 2017 Jul-Aug;38(4):383-389. doi: 10.1016/j.amjoto.2017.03.006. Epub 2017 Apr 4.</citation>
    <PMID>28390807</PMID>
  </results_reference>
  <results_reference>
    <citation>Weissman JD, Fernandez F, Hwang PH. Xylitol nasal irrigation in the management of chronic rhinosinusitis: a pilot study. Laryngoscope. 2011 Nov;121(11):2468-72. doi: 10.1002/lary.22176. Epub 2011 Oct 12. Erratum In: Laryngoscope. 2012 Nov;122(11):2611.</citation>
    <PMID>21994147</PMID>
  </results_reference>
  <results_reference>
    <citation>Isogangas P, Makinen KK, Tiekso J, Alanen P. Long-term effect of xylitol chewing gum in the prevention of dental caries: a follow-up 5 years after termination of a prevention program. Caries Res. 1993;27(6):495-8. doi: 10.1159/000261587.</citation>
    <PMID>8281565</PMID>
  </results_reference>
  <results_reference>
    <citation>Uhari M, Kontiokari T, Niemela M. A novel use of xylitol sugar in preventing acute otitis media. Pediatrics. 1998 Oct;102(4 Pt 1):879-84. doi: 10.1542/peds.102.4.879.</citation>
    <PMID>9755259</PMID>
  </results_reference>
  <results_reference>
    <citation>Jain R, Lee T, Hardcastle T, Biswas K, Radcliff F, Douglas R. The in vitro effect of xylitol on chronic rhinosinusitis biofilms. Rhinology. 2016 Dec 1;54(4):323-328. doi: 10.4193/Rhino15.380.</citation>
    <PMID>27394715</PMID>
  </results_reference>
  <results_reference>
    <citation>Piromchai P, Kasemsiri P, Laohasiriwong S, Thanaviratananich S. Chronic rhinosinusitis and emerging treatment options. Int J Gen Med. 2013 Jun 7;6:453-64. doi: 10.2147/IJGM.S29977. Print 2013.</citation>
    <PMID>23785241</PMID>
  </results_reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ochsner Health System</investigator_affiliation>
    <investigator_full_name>Edward Mccoul, MD</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <keyword>chronic rhinosinusitis</keyword>
  <keyword>chronically draining sinus</keyword>
  <keyword>condemned sinus</keyword>
  <keyword>post-endoscopic sinus surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03229551
org study id: 2017.317.B
nct id: NCT03229551
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: 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
description: 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.
measure: Sino-Nasal Outcome Test-22 (SNOT-22)
time frame: 3 months
description: Maximum score of 110 points based on responses to 22 questions
measure: Brief Smell Identification Test (BSIT)
time frame: 3 months
description: Total scores range from 0 to 12; higher scores indicate greater olfactory function
measure: Endoscopic appearance of the patient's sinuses in response to the use of topical xylitol
time frame: 3 months
measure: Correlation of DNA seqeuncing results with conventional sinonasal cultures
time frame: 3 months
arm group label: Xylitol
arm group type: Experimental
description: 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.
arm group label: Control
arm group type: Active Comparator
description: This arm is the standard of care saline irrigation solution.
intervention type: Drug
intervention name: Xylitol
description: 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.
arm group label: Xylitol
intervention type: Drug
intervention name: Saline
description: 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.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Harvey RJ, Psaltis A, Schlosser RJ, Witterick IJ. Current concepts in topical therapy for chronic sinonasal disease. J Otolaryngol Head Neck Surg. 2010 Jun;39(3):217-31.
PMID: 20470665
citation: Al-Mutairi D, Kilty SJ. Bacterial biofilms and the pathophysiology of chronic rhinosinusitis. Curr Opin Allergy Clin Immunol. 2011 Feb;11(1):18-23. doi: 10.1097/ACI.0b013e3283423376.
PMID: 21150431
citation: Hoggard M, Wagner Mackenzie B, Jain R, Taylor MW, Biswas K, Douglas RG. Chronic Rhinosinusitis and the Evolving Understanding of Microbial Ecology in Chronic Inflammatory Mucosal Disease. Clin Microbiol Rev. 2017 Jan;30(1):321-348. doi: 10.1128/CMR.00060-16.
PMID: 27903594
citation: Rosen PL, Palmer JN, O'Malley BW Jr, Cohen NA. Surfactants in the management of rhinopathologies. Am J Rhinol Allergy. 2013 May-Jun;27(3):177-80. doi: 10.2500/ajra.2013.27.3873.
PMID: 23710951
citation: Riley P, Moore D, Ahmed F, Sharif MO, Worthington HV. Xylitol-containing products for preventing dental caries in children and adults. Cochrane Database Syst Rev. 2015 Mar 26;2015(3):CD010743. doi: 10.1002/14651858.CD010743.pub2.
PMID: 25809586
citation: Sakallioglu O, Guvenc IA, Cingi C. Xylitol and its usage in ENT practice. J Laryngol Otol. 2014 Jul;128(7):580-5. doi: 10.1017/S0022215114001340. Epub 2014 Jul 7.
PMID: 24999540
citation: Shashy RG, Moore EJ, Weaver A. Prevalence of the chronic sinusitis diagnosis in Olmsted County, Minnesota. Arch Otolaryngol Head Neck Surg. 2004 Mar;130(3):320-3. doi: 10.1001/archotol.130.3.320.
PMID: 15023840
citation: Cryer J, Schipor I, Perloff JR, Palmer JN. Evidence of bacterial biofilms in human chronic sinusitis. ORL J Otorhinolaryngol Relat Spec. 2004;66(3):155-8. doi: 10.1159/000079994.
PMID: 15316237
citation: Antunes MB, Feldman MD, Cohen NA, Chiu AG. Dose-dependent effects of topical tobramycin in an animal model of Pseudomonas sinusitis. Am J Rhinol. 2007 Jul-Aug;21(4):423-7. doi: 10.2500/ajr.2007.21.3046.
PMID: 17882910
citation: Chiu AG, Antunes MB, Palmer JN, Cohen NA. Evaluation of the in vivo efficacy of topical tobramycin against Pseudomonas sinonasal biofilms. J Antimicrob Chemother. 2007 Jun;59(6):1130-4. doi: 10.1093/jac/dkm087. Epub 2007 Apr 3.
PMID: 17405780
citation: Brown CL, Graham SM, Cable BB, Ozer EA, Taft PJ, Zabner J. Xylitol enhances bacterial killing in the rabbit maxillary sinus. Laryngoscope. 2004 Nov;114(11):2021-4. doi: 10.1097/01.mlg.0000147939.90249.47.
PMID: 15510034
citation: Cain RB, Lal D. Update on the management of chronic rhinosinusitis. Infect Drug Resist. 2013;6:1-14. doi: 10.2147/IDR.S26134. Epub 2013 Jan 23.
PMID: 23378777
citation: Lin L, Tang X, Wei J, Dai F, Sun G. Xylitol nasal irrigation in the treatment of chronic rhinosinusitis. Am J Otolaryngol. 2017 Jul-Aug;38(4):383-389. doi: 10.1016/j.amjoto.2017.03.006. Epub 2017 Apr 4.
PMID: 28390807
citation: Weissman JD, Fernandez F, Hwang PH. Xylitol nasal irrigation in the management of chronic rhinosinusitis: a pilot study. Laryngoscope. 2011 Nov;121(11):2468-72. doi: 10.1002/lary.22176. Epub 2011 Oct 12. Erratum In: Laryngoscope. 2012 Nov;122(11):2611.
PMID: 21994147
citation: Isogangas P, Makinen KK, Tiekso J, Alanen P. Long-term effect of xylitol chewing gum in the prevention of dental caries: a follow-up 5 years after termination of a prevention program. Caries Res. 1993;27(6):495-8. doi: 10.1159/000261587.
PMID: 8281565
citation: Uhari M, Kontiokari T, Niemela M. A novel use of xylitol sugar in preventing acute otitis media. Pediatrics. 1998 Oct;102(4 Pt 1):879-84. doi: 10.1542/peds.102.4.879.
PMID: 9755259
citation: Jain R, Lee T, Hardcastle T, Biswas K, Radcliff F, Douglas R. The in vitro effect of xylitol on chronic rhinosinusitis biofilms. Rhinology. 2016 Dec 1;54(4):323-328. doi: 10.4193/Rhino15.380.
PMID: 27394715
citation: Piromchai P, Kasemsiri P, Laohasiriwong S, Thanaviratananich S. Chronic rhinosinusitis and emerging treatment options. Int J Gen Med. 2013 Jun 7;6:453-64. doi: 10.2147/IJGM.S29977. Print 2013.
PMID: 23785241
responsible party type: Principal Investigator
investigator affiliation: Ochsner Health System
investigator full name: Edward Mccoul, MD
investigator title: Physician
mesh term: Sinusitis
sharing ipd: No
ipd 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.