Effect of a L. Paracasei Strain on Grass Pollen Allergic Rhinitis Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Nasal reaction threshold when provocation test with allergens
研究概览
简要总结
Various studies in animal and humans have shown a potential beneficial effect of probiotics consumption on allergy. However few studies exist that document their efficacy for upper airways allergies such as allergic rhinitis. The objective of this study is to investigate the effect of short-term oral administration of a L. paracasei or of a blend of 2 probiotics (L. acidophilus + B. lactis) on a nasal provocation test (NPT) with grass pollen, performed out of the pollen season. Adult volunteers with allergic rhinitis are enrolled in a randomized, double-blind study, based on two 4-weeks cross-over periods of product consumption separated by a washout period of 6-8 weeks. Objective and subjective clinical parameters of NPT as well as systemic and nasal immunological markers are compared before and after each treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-40 years old
- •history of allergic rhinitis during the latest grass pollen season confirmed by a positive skin prick test to grass pollen (wheal diameter > 3mm) and a positive response to a NPT with grass pollen (combined nasal reaction threshold <= 10000 standardized quality units/ml at the screening phase
排除标准
- •any medical condition that could influence the study (pregnancy, viral or bacterial airway infection, active allergic rhinitis)
- •uncontrolled asthma (peak expiratory flow <20% of volunteer's best personal value)
- •treatment with antihistamine or antibiotic treatment less than two weeks before enrolment or during the trial
研究组 & 干预措施
L. acidophilus + B. lactis
L. acidophilus + B. lactis
干预措施: probiotic (Dietary Supplement)
L. paracasei
L. paracasei
干预措施: probiotic (Dietary Supplement)
结局指标
主要结局
Nasal reaction threshold when provocation test with allergens
时间窗: 4 weeks
次要结局
未报告次要终点
