Safety and Efficacy of Lactococcus Lactis Probiotic Bacteria for the Treatment of Chronic Rhinosinusitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Sino-nasal symptom score
研究概览
简要总结
Despite advances in medical treatments and surgery for chronic rhinosinusitis (CRS), there remains a large number of patients who continue to suffer from chronic sinusitis despite standard therapies. This research project has the goal of evaluating the safety and effectiveness of a potentially novel therapy for patients with CRS refractory to medical and surgical therapies, consisting of the introduction of a live probiotic bacteria (L lactis W136) directly into the nasal and sinus cavities via irrigation.
In total, 24 patients suffering from refractory CRS will be recruited from ongoing clinical activities by the research team of Martin Desrosiers at the CHUM hospital. Study duration is six weeks, and will be performed in three phases, with six visits planned in total.
- Two-week observation period where only saline irrigation is administered.
- Treatment period of 14 days (D0 to D14) during which L lactis W136 will be administered twice-daily.
- Post treatment observation period of two weeks (D14 to D28) during which the patient will cease probiotic but will continue to irrigate his nose with only saline.
Assessment will use symptom questionnaires, quality of life questionnaires and endoscopic examination of the sinus cavities. Sinus culture will be performed at each visit to assess development of unusual infections. Exploratory assessments of gene expression and microbiome profiling will be performed to explore underlying mechanisms.
详细描述
CONTEXT/JUSTIFICATION:
Chronic rhinosinusitis (CRS) is one of the most frequent chronic diseases and has a significant negative impact on quality of life (QOL) in patients who suffer from it. Despite advances in medical treatments and surgery, there remains a large number of patients who continue to suffer from chronic sinusitis despite standard therapies. This research project has the goal of evaluating the safety and effectiveness of a potentially novel therapy for chronic sinusitis, via introduction of a probiotic bacteria (L lactis W136) directly into the nasal and sinus cavities via irrigation.
Probiotics are living micro-organisms (bacteria or fungi), which are added his compliments to certain dietary products such as yogurt to cereals with the intended effect of a beneficial effect on host health. The World Health Organization (WHO) and the league of the United Nations for Foodstuffs and Agriculture have defined probiotics as "living micro-organisms, which, when administered in sufficient quantity, exercise a positive effect on health beyond those of traditional nutritional benefits".
GOALS OF THERAPY:
To study the safety and clinical efficacy of an intranasal treatment with probiotic L lactis W136 in a population of patients with rhinosinusitis CRS refractory to medical and surgical therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •refractory chronic rhinosinusitis (CRS)
- •persistence of symptoms of CRS despite previous endoscopic sinus surgery (ESS) and ongoing medical management
排除标准
- •patients <18 years
- •cystic fibrosis
- •technical reasons for ESS failure
- •active sinus infection with purulence pain and/or hyperthermia
- •immune suppression from disease or medication.
研究组 & 干预措施
Saline irrigation
Each participant performed nasal saline irrigation at 2 periods:
- Day -14 to Day 0
- Day 14 to Day 28
干预措施: Topical probiotic treatment with Lactococcus lactis W136 (Other)
Saline irrigation
Each participant performed nasal saline irrigation at 2 periods:
- Day -14 to Day 0
- Day 14 to Day 28
干预措施: Saline irrigation (Other)
Probiotic lactococcus lactis W136 irrigation
Each participant performed Probiotic lactococcus lactis W136 nasal irrigation from Day 0 to D14
干预措施: Topical probiotic treatment with Lactococcus lactis W136 (Other)
Probiotic lactococcus lactis W136 irrigation
Each participant performed Probiotic lactococcus lactis W136 nasal irrigation from Day 0 to D14
干预措施: Saline irrigation (Other)
结局指标
主要结局
Sino-nasal symptom score
时间窗: 6 weeks
Subjective symptoms of nasal function. The sino-nasal symtom score (SNSS) is the sum of the following nasal and sinus symptoms: 1. Nasal obstruction 2. Facial pain 3. Need to blow nose 4. Headache 5. Post-nasal drip Each individual item is scored on a 0-3 ordinal scale, with a higher score indicating a worst/more severe symptom. The TNSS is the sum of the five symptoms and has a range of 0-15. A lower score is better.
次要结局
- Sinus culture (conventional)(6 weeks)
- SNOT-22(6 weeks)
- Post Operative Sinus Endoscopy Score (POSE)(6 weeks)