Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT03229551
Status:
COMPLETED
Last Update Posted:
2023-04-07
First Post:
2017-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Xylitol for Chronic Sinusitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096825', 'term': 'Rhinosinusitis'}, {'id': 'D012852', 'term': 'Sinusitis'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014993', 'term': 'Xylitol'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2017-07-21', 'studyFirstSubmitQcDate': '2017-07-21', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention.', 'timeFrame': '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.'}], 'secondaryOutcomes': [{'measure': 'Sino-Nasal Outcome Test-22 (SNOT-22)', 'timeFrame': '3 months', 'description': 'Maximum score of 110 points based on responses to 22 questions'}, {'measure': 'Brief Smell Identification Test (BSIT)', 'timeFrame': '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", 'timeFrame': '3 months'}, {'measure': 'Correlation of DNA seqeuncing results with conventional sinonasal cultures', 'timeFrame': '3 months'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic rhinosinusitis', 'chronically draining sinus', 'condemned sinus', 'post-endoscopic sinus surgery'], 'conditions': ['Chronic Rhinosinusitis', 'Rhinosinusitis', 'Sinusitis', 'Drain Sinus', 'Endoscopic Sinus Surgery', 'Biofilms', 'Bacterial Overgrowth']}, 'referencesModule': {'references': [{'pmid': '20470665', 'type': 'BACKGROUND', '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': '21150431', 'type': 'BACKGROUND', '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': '27903594', 'type': 'BACKGROUND', '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': '23710951', 'type': 'BACKGROUND', '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': '25809586', 'type': 'BACKGROUND', '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': '24999540', 'type': 'BACKGROUND', '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': '15023840', 'type': 'RESULT', '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': '15316237', 'type': 'RESULT', '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': '17882910', 'type': 'RESULT', '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': '17405780', 'type': 'RESULT', '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': '15510034', 'type': 'RESULT', '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': '23378777', 'type': 'RESULT', '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': '28390807', 'type': 'RESULT', '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': '21994147', 'type': 'RESULT', '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.'}, {'pmid': '8281565', 'type': 'RESULT', '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': '9755259', 'type': 'RESULT', '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': '27394715', 'type': 'RESULT', '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': '23785241', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Problem Statement:\n\nThe 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.\n\nPurpose of Study/Potential Impact:\n\nThe 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.\n\nPotential Benefits:\n\nTopical 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.\n\nPotential Risks:\n\nPotential risks are minimal but include a sweet aftertaste in the mouth and burning in the nose; which have been reported in previous studies.\n\nHypothesis:\n\n5% (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.\n\nGeneral Design:\n\nA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients above the age of 18\n* History of chronic rhinosinusitis history who had undergone bilateral endoscopic sinus surgery to include at a minimum maxillary antrostomy and anterior ethmoidectomy.\n* Continued chronic sinusitis that is refractory to medical therapy after surgical intervention\n\nExclusion Criteria:\n\n* Patients under age of 18\n* Non-English speaking\n* History of immunodeficiency disease\n* Cystic fibrosis\n* Primary ciliary dyskinesia\n* History of granulomatous disease\n* Active smoker\n* Treatment with antifungal medications\n* Use of antifungal medications\n* Acute bacterial infection requiring antibiotics\n* Active pregnancy'}, 'identificationModule': {'nctId': 'NCT03229551', 'briefTitle': 'Xylitol for Chronic Sinusitis', 'organization': {'class': 'OTHER', 'fullName': 'Ochsner Health System'}, 'officialTitle': 'Xylitol Topical Irrigation for Treatment of Recalcitrant Chronic Sinusitis', 'orgStudyIdInfo': {'id': '2017.317.B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xylitol', '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.', 'interventionNames': ['Drug: Xylitol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'This arm is the standard of care saline irrigation solution.', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Xylitol', 'type': 'DRUG', '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.', 'armGroupLabels': ['Xylitol']}, {'name': 'Saline', 'type': 'DRUG', '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.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ochsner Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tulane University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Edward Mccoul, MD', 'investigatorAffiliation': 'Ochsner Health System'}}}}