NCT01013259已完成2 期
Explorative Analysis of the Immunomodulatory Capacities of Apathogenic Escherichia Coli Nissle 1917 in Patients With Rhinoconjunctivitis Due to Grass Pollen Allergy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- symptom-medication score
研究概览
简要总结
Due to the worldwide increasing prevalence of the allergic rhinoconjunctivitis, new therapeutical strategies are needed. The symptomatic treatment with topical and systemic antihistamines and corticosteroids are often insufficient. E.coli Nissle 1917 has immunomodulatory capacities and reveals less side effects. E.coli Nissle 1917 has no sedative properties and exhibits no hepatotoxic qualities. Thus, E.coli Nissle 1917 represents a new relevant therapeutical agent.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical relevant grass pollen allergy with required treatment since 2 years
- •positive skin prick test to grass
- •positive sIgE towards grass (CAP 2)
- •written informed consent
排除标准
- •perennial rhinoconjunctivitis
- •sinusitis
- •chronic diarrhoea and other existing severe gastrointestinal diseases
- •current specific immunotherapy to grass pollen
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Mutaflor
Experimental
干预措施: Mutaflor (Drug)
结局指标
主要结局
symptom-medication score
时间窗: 45 days
次要结局
未报告次要终点
研究者
研究点 (1)
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