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临床试验/EUCTR2008-006335-12-DE
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:
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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

发起方
Prof. Dr. med. Margitta Worm

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