Xylitol Topical Irrigation for Treatment of Recalcitrant Chronic Sinusitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- The effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Xylitol (Drug)
Control
This arm is the standard of care saline irrigation solution.
干预措施: Saline (Drug)
结局指标
主要结局
The effect of topical xylitol therapy on biofilm production with the use of PCR bacterial sequencing before and after medical intervention.
时间窗: 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.
次要结局
- Brief Smell Identification Test (BSIT)(3 months)
- Sino-Nasal Outcome Test-22 (SNOT-22)(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)
研究者
Edward Mccoul, MD
Physician
Ochsner Health System