Xylitol for Chronic Sinusitis

NCT03229551 | Completed Phase 2

• 1 other identifier: 2017.317.B
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

chronic rhinosinusitis; chronically draining sinus; condemned sinus; post-endoscopic sinus surgery

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 months

Secondary Outcomes (4)

• Sino-Nasal Outcome Test-22 (SNOT-22)

  3 months

• Brief Smell Identification Test (BSIT)

  3 months

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

  3 months

• Correlation of DNA seqeuncing results with conventional sinonasal cultures

  3 months

Study Arms (2)

Xylitol

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

This arm is the standard of care saline irrigation solution.

Drug: Saline

Interventions

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.

Xylitol

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ochsner Health System: lead
• Tulane University School of Medicine: collaborator

Study Sites (1)

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Related Publications (18)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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: 21994147 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Rhinosinusitis; Sinusitis

Interventions

Xylitol; Sodium Chloride

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 25, 2017
• Study Start: March 1, 2018
• Primary Completion: July 16, 2018
• Study Completion: July 16, 2018
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)