Mitigation of Seasonal Allergic Rhinitis Symptoms in Adults by Probiotic Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Total nasal symptom score (TNSS)
研究概览
简要总结
The purpose of the current study is to evaluate the efficacy of administering a probiotic in adult human subjects suffering from allergic rhinitis during seasonal grass pollen exposure.
详细描述
Adult subjects with documented seasonal allergic rhinitis (SAR) to grass pollen will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 8 weeks during the grass pollen allergy season. Total nasal symptom score (TNSS) will be compared over 8 weeks between the two treatment groups.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Adults aged 18 to 65 years of age at the time of enrolment.
- •Established seasonal allergic rhinitis (clinical history of rhinorrhea, congestion, sneezing, pruritis >2 years)
- •Positive Skin Prick Test (SPT)to Grass Pollen (GP).
- •Presence of specific IgE to Grass Pollen (GP)
- •Have a Body Mass Index in the range 19-32 kg/m2
- •Have signed the consent form
- •Have been instructed during screening and agreed to not take any probiotic containing products outside the study for the study period
排除标准
- •Subjects currently under treatment with antibiotics or undergoing allergen immunotherapy at the time of enrolment
- •Pregnancy
- •Vasomotor rhinitis, nasal cavity disorders (nasal polyps), ear infections otitis media).
- •Other chronic diseases (e.g. gastrointestinal, cardiovascular, infections)
- •Subjects diagnosed with asthma
- •Subjects currently participating in another interventional clinical trial or having participated in another clinical trial in the last 2 months
- •Subjects on chronic use of systemic corticosteroids prior to randomization
结局指标
主要结局
Total nasal symptom score (TNSS)
时间窗: every day over 8 weeks
Total nasal symptom score (TNSS) measuring nasal congestion, runny nose, nasal itching and sneezing on a scale of 0-12 will be compared over 8 weeks between the two treatment groups.
次要结局
- Well being index(every week over 8 weeks)
- Specific IgE(Baseline and end of study)
- miniRQLQ(every week for 8 weeks)
- Total ocular symptom score (TOSS)(every day over 8 weeks)
- Individual nasal and ocular symptoms scores(every day over 8 weeks)
- Medication Score(every week over 8 weeks)