Xylitol for Chronic Sinusitis
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|ClinicalTrials.gov Identifier: NCT03229551|
Recruitment Status : Not yet recruiting
First Posted : July 25, 2017
Last Update Posted : July 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rhinosinusitis||Drug: Xylitol Drug: Saline||Phase 2 Phase 3|
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.
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 are minimal but include a sweet aftertaste in the mouth and burning in the nose; which have been reported in previous studies.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Xylitol Topical Irrigation for Treatment of Recalcitrant Chronic Sinusitis|
|Anticipated Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||September 30, 2018|
|Estimated Study Completion Date :||December 31, 2018|
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.
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.
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.
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229551
|Contact: Edward McCoul, MD, MPHemail@example.com|
|Contact: Azad Hussain, MPHfirstname.lastname@example.org|