NCT03073837已完成不适用
RUDOLPH Study Nasal Microbiota and Concurrent Nose Soreness Associated With Common Cold Infection - a Pilot Using the HRV-16 Challenge Model in Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- nasal microbiota composition and occurrence of nose redness and soreness during rhinovirus infection
研究概览
简要总结
This pilot study will utilize the experimental rhinovirus infection model to study changes in skin microbiota in relation to skin erythema and soreness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •self reported proneness to developing symptoms of nose redness and/or soreness
- •sero-negative to HRV-16 at screening
排除标准
- •confirmed or self-reported allergic rhinitis
- •history of nasal or otologic surgery
- •use of anti-inflammatory medication, recent antibiotics or anti-histamines
研究组 & 干预措施
Rhinovirus Challenge
Other
Challenge with HRV-16
干预措施: Rhinovirus Challenge (Other)
结局指标
主要结局
nasal microbiota composition and occurrence of nose redness and soreness during rhinovirus infection
时间窗: change from baseline compared to day 22
Taxonomic classification of bacterial strains before and after HRV-16 virus for subjects with a VAS score rating \>37mm
次要结局
未报告次要终点
研究者
研究点 (2)
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