Prospective Longitudinal Observational Research Study to Investigate the Remission of Atopic Dermatitis and Associated Allergic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Remission of atopic dermatitis and associated allergic diseases
研究概览
简要总结
Atopic dermatitis (AD) is a frequent chronic relapsing inflammatory skin disorder, characterized by intensely itchy eczema. AD usually starts within the first 2 years of life. In 30 - 60% of children, inflammation spreads onto other body surfaces such as the gastrointestinal tract, the respiratory tract, and the conjunctives within a few years. This sequence is called atopic march.
Atopic dermatitis and associated atopic diseases are more frequent in families, suggesting a genetic predisposition. However, the underlying factors such as genetic phenotype, environmental factors, or life style which cause or worsen an existing allergic disease are not understood yet. Affected people suffer from recurrent flares that result in significantly impaired quality.
This study will collect clinical and laboratory data to elucidate immunotolerance and preventiv stategies with the aim to develop new and individual treatment options of atopic diseases.
详细描述
Primary Objetive:
In the planned project, the main objective is to identify endogenous (e.g. immunological and molecular factors) and exogenous factors (e.g. environmental, socioeconomic and microbial factors) that influence the course and remission of AD. More specifically to identify factors that are significantly different between patients that have or do not have remission from AD.
Secondary Objective:
(i) To identify endogenous and exogenous factors such as immunological, molecular and microbial factors to separate subgroups of patients (endotypes) with distinct local and systemic inflammatory responses.
(ii) To identify potential biomarkers predicting the individual clinical course of AD and other atopic diseases including asthma, food allergy and allergic rhinitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 0 - 85 years
- •Diagnosis of AD and/or another disease of the atopic group (i.e. allergic rhinitis, allergic asthma, food allergy)
- •The inclusion of patients in this study is independent from the current therapy. During the study all patients will be kept on a therapy that is medically indicated
- •The inclusion criteria for healthy controls in this study are as follows:
- •Age 0 - 85 years
- •No diagnosis or history of allergic disease
- •The inclusion of patients in this study is independent from the current therapy. During the study all patients will be kept on a therapy that is medically indicated
- •Written consent will be obtained after detailed information of the study was given to the participant.
排除标准
- •- Unable to give consent or refusal to participate in the study
结局指标
主要结局
Remission of atopic dermatitis and associated allergic diseases
时间窗: 5 years
Prospective observational study
次要结局
- Endogenous and exgogenouse factors that influence and predict the course of AD.(5 years)
- Identification of potential biomarkers predicting the course of AD(5 years)