NCT01779895已完成不适用
Effect of Probiotic Lactobacillus Paracasei NCC2461 on House Dust Mite Allergy
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2012年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of a probiotic strain in improving the quality of life in adult subjects suffering from perennial allergic rhinit.
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
- Quadruple (Participant, Care Provider, 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
- •Adults between 20-65 years old
- •Confirmed allergy (allergic rhinitis) to dust mite for more than 2 years, as determined by anamnesis and by a miniRQLQ of ≥ 1
- •Positive Skin prick testing measure greater than 3mm wheal diameter to the dermatophagoides pteronyssinus species of house dust mite extract
- •Body Mass Index 19-29
- •Having obtained his/her informed consent
排除标准
- •Allergy to any food or medication
- •Family history of congenital immunodeficiency or chronic consumption (more than one week at Screening) of immunosuppressive or anti-inflammatory treatments
- •Ongoing treatment with antibiotics or undergoing allergen immunotherapy at Screening
- •Consumption of probiotic and other dietary nutritional interventions
- •More than 2 drinks/day alcohol consumption or use of illicit drugs
- •Pregnant women
- •Subjects with expected low compliance
- •Blood donation in the past month or planning to donate blood until a month after the end of the study
- •Currently participating or having participated in another interventional clinical trial during the last four weeks prior to the beginning the study
结局指标
主要结局
Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ)
时间窗: 8 weeks
Compared over 8 weeks between the two treatment groups
次要结局
- Basophil activation in ex-vivo stimulated whole blood cells(Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks)
- Level of pro-inflammatory cytokines in ex-vivo stimulated whole blood cells(Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks)
- Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Medication score(Measured weekly for the 8 weeks of product intake)
- Level of Specific Immunoglobulin E(Measured 2 times: at the start of product intake and after 8 weeks)
- Frequency of adverse events(during the 8 weeks of product intake)
研究者
研究点 (2)
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