Immune-modulatory Effect of Candidate Probiotic Strain on Whole Blood Cells of Grass Pollen Allergic Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)
研究概览
简要总结
The purpose of the current study is to evaluate the effect of administering a probiotic strain on allergic symptoms and immune parameters (Th-2 cytokines, effector cells) in seasonal allergic rhinitis subjects.
详细描述
To identify immune markers in allergic individuals that are impacted by probiotic treatment during seasonal exposure
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed allergy (allergic rhinitis) to grass pollen > 1 year and positive SPT > 3mm wheal diameter to grass pollen.
- •Age 20-65 years adults
- •Body Mass Index 19- 29 (people in the normal and overweight range)
- •Having obtained his/her informed consent.
排除标准
- •Family history of congenital immunodeficiency
- •Regular consumption of immunosuppressive or anti-inflammatory treatment
- •Under medication against allergy (e.g. anti histaminic)
- •Avoid regular consumption of probiotic and other dietary nutritional interventions
- •Have a high alcohol consumption (more than 1 drink/day)
- •Consumption of illicit drugs
- •Pregnancy
- •Subject who cannot be expected to comply with the study procedures, including consuming the test products
- •Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
研究组 & 干预措施
Probiotic
probiotic blended in maltodextrin
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)
时间窗: 0 (baseline), 1, and 2 months
A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.
Comparison of Th2 Cytokines (IL-13) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)
时间窗: 0 (baseline), 1 and 2 months
A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.
次要结局
- Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake)(Measures at baseline, 1, and 2 months)
- Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells(8 weeks)
- Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups(8 weeks)
- Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells(8 weeks)