NCT00677209已完成1 期
Frankfurt Investigator-initiated Autovaccine-study
Johann Wolfgang Goethe University Hospital2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2006年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Patients' clinical parameters and behaviour, laboratory values
研究概览
简要总结
House dust mite allergy is a common problem, resulting in asthma, chronic swelling of the eyes, and running nose. The investigators test a possibility to immunize subjects sensitized against house dust mite with extracts from their own gut bacteria "auto-vaccination".
详细描述
see above
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •age 18-35 years
- •known allergy on house-dust mite
排除标准
- •anamnestic incompatibility to parts of autovaccine
- •asthma > GINA I°
- •chronic disease conditions or infections
- •pregnancy
- •inhalative or systemic steroid use
- •any immunosuppressive therapy
- •intake of any other probiotic medication (e.g. E.coli nissle 1917)
- •participation in any other study at the same time
- •substance abuse
- •Incapability of understanding the study's purpose and performance
结局指标
主要结局
Patients' clinical parameters and behaviour, laboratory values
时间窗: jul 2006 - august 2008
laboratory testing reflecting function of bone marrow, liver, kidney
时间窗: jul 2006- august 2008
次要结局
- Lung function,exhalative NO(jul 2006 - oct 2007)
研究者
研究点 (2)
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