ADELE: Autoimmune Defense and Living Environment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Blood serum levels of antibodies caused by Prevenar 13 vaccine in different arms (intervention versus no intervention)
研究概览
简要总结
The effect of microbial exposure on healthy human subjects will be investigated. Changes in cytokine and IgE and vaccine response will be measured. The hypothesis is that microbial exposure increases the measured responses.
详细描述
The effect of microbial exposure on healthy human subjects will be investigated. The volunteers will either receive material containing a microbial inoculum, or they will receive nothing. Changes in cytokine and IgE and vaccine response will be measured. Subjective well-being will be recorded. Changes in microbial community will be followed. The hypothesis is that microbial exposure increases the measured responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults that live in urban conditions; that do not own a furry pet; that do not have HIV or other condition that weakens immune system; that do not use drugs chilling immune system; that do not have a history of five active infections that caused hospitalization within 2 years; that do not have a condition affecting immune response (e.g. rheumatoid, colitis ulcerosa, Crohn disease); that do not have dementia, acute depression or psychosis; that do not have cancer within 2 years; that do not have sore skin in arms or hands; that do not have diabetes; that do not have incompetency; that have not received earlier vaccine against Pneumococcus sp.; that do not have unwillingness to receive the vaccine; that do not live in countryside.
排除标准
- 未提供
研究组 & 干预措施
Exposed group
these volunteers receive microbial inoculate
干预措施: microbial inoculate (Biological)
control
these volunteers do not receive microbial inoculate
结局指标
主要结局
Blood serum levels of antibodies caused by Prevenar 13 vaccine in different arms (intervention versus no intervention)
时间窗: 1-3 months
it will be checked if the values are different in different arms. Prevenar 13 is a vaccine against various Pneumococcus sp. infections
difference in blood serum's cytokine levels
时间窗: 1-3 months
it will be checked if the values are different in different arms
difference in blood serum IgE levels
时间窗: 1-3months
in will be chekced if the values are different in different arms
次要结局
- difference in diversity (Shannon-Wiener index) of the composition of skin, stool and saliva bacterial community(1-3 months)
- difference in richness (number of operational taxonomic units i.e. species) of the composition of skin, stool and saliva bacterial community(1-3 months)
- Number of participants with treatment-related adverse events as assessed by a questionnaire described below(1-3 months)
研究者
Aki Sinkkonen
University researcher, docent
University of Helsinki