EUCTR2008-006335-12-DE进行中(未招募)1 期
Explorative analysis of the immunmodulatory capacities of apathogenic Escherichia coli Nissle 1917 in patients with rhinoconjunctivitis due to grass pollen allergy.
Prof. Dr. med. Margitta Worm0 个研究点目标入组 34 人开始时间: 2008年10月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age between 18 and 65 years (women and men)
- •Clinical relevat grass pollen allergy with required treatment of the rhinoconjunctivitis symptoms since at least 2 years
- •Positive skin prick test (SPT) to grass pollen extract
- •Positive specific IgE towards grass pollen (at least CAP class 2)
- •Written inform consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Perennial rhinoconjunctivitis
- •Chronic diarrhoe and other existing severe gastrointestinale diseases
- •Asthma bronchiale (Gina II - IV)
- •Use of Mutaflor® 12 weeks before the start of the trial
- •Use of antibiotics towards gram negative bacteria 4 weeks before the start of the trial
- •Specific immunotherapy to grass pollen 6 months before the start of the trial
- •Current specific immunotherapy to any allergen
- •Female patients: pregnancy and lactation period
- •Severe cardiovascular diseases and metabolic disorders, autoimmune diseases or other systemic inflammatory disorders
研究者
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