Environmental Impact and Immune Responses in Atopic Dermatitis Patients in Central Europe and Sub-Saharan Africa: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Cutaneous immune response
研究概览
简要总结
Many people are affected by atopic dermatitis (AD) worldwide. However, clinical studies on AD in Sub-Saharan Africa are rare and there is a lack of knowledge about possible differences in pathogenesis between European and African AD.
This study will collect clinical and laboratory data with the aim to compare clinical characteristics and immune responses in AD patients in Sub-Saharan Africa and Central Europe. Furthermore, relevant allergens as well as the nasal, skin and gut micro- and mycobiome will be investigated.
详细描述
Objectives of the project: Compare the following aspects in patients suffering from atopic dermatitis (AD) and healthy control (HC) participants in Central Europe (CE) vs. Sub-Saharan Africa (SsA):
- Clinical characteristics, life quality, treatments, and family history
- Immune mapping and barrier characterization of lesional and non-lesional skin
- Exploration of the serological and cutaneous immune signatures
- Investigation of the skin, nasal and gut microbiome (including bacteria and fungi)
- Comparison of the sensitization patterns and putting it into clinical context (food questionnaire, anamnesis about allergic symptoms, analysis of IgE and IgG levels)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AD patients:
- •Age: ≥18 years
- •Written informed consent given after information about the research project
- •Suffering from active atopic dermatitis
- •No active skin disease other than atopic dermatitis
- •No known active inflammatory disease other than atopic dermatitis/atopic diseases
- •HC participants:
- •Age: ≥18 years
- •Written informed consent given after information about the research project
- •No active skin disease
- •No known atopic disease (atopic dermatitis, asthma, allergy, allergic rhinoconjuncitivitis)
- •No known active inflammatory disease
排除标准
- •Known or suspected systemic immunosuppression because of disease
- •Systemic immunomodulatory/-suppressive treatment
- •Glucocorticoids or immunosuppressants (last 4 weeks) or
- •JAK inhibitors (last week) or
- •Omalizumab (last 4 weeks) or
- •Other biologicals e.g. dupilumab (last 2 months)
- •Clinical signs of active bacterial, fungal or viral infection
- •Systemic antibiotic, antimycotic or antiviral treatment 4 weeks prior to start
- •Phototherapy 4 weeks prior to start
- •Active neoplasia
- •Undergoing surgery in the last 2 months
- •Infarction (e.g. stroke), embolism, or thrombosis in the last 2 months
- •Inability to follow the study procedures e.g. due to language problems, dementia etc. of the participant
结局指标
主要结局
Cutaneous immune response
时间窗: Day 0
* Skin biopsies are optional and will be taken from lesional and non-lesional skin * They will be analyzed by imaging mass cytometry and spatial gene expression analysis
Barrier dysfunction of the skin (Spatial gene expression analysis)
时间窗: Day 0
Skin biopsies are optional and will be taken from lesional and non-lesional skin
Skin microbiome (microbial colonization of the skin)
时间窗: Day 0
* Skin swabs will be taken at the following localizations: Antecubital crease, glabella, vertex, dorsal neck and lesional skin site * Analysis by isolation and sequencing of the microbial DNA
Total and specific IgE and IgG levels
时间窗: Day 0
Will be put into clinical context with a questionnaire about food intake and allergic symptoms
Questionnaire about the presence of allergic symptoms
时间窗: Day 0
Information about symptoms upon allergen exposure
Description of clinical appearance of AD on black vs. white skin
时间窗: Day 0
Appearance, severity and distribution of the skin lesions
Nasal microbiome (microbial colonization of the nasal vestibule)
时间窗: Day 0
* A nasal swab will be taken upon day 0 * It will be used to grow cultures and analyse the microbial DNA
Questionnaire about food intake
时间窗: Day 0
Information about how often the participants are consuming certain foods
Stigmata of atopic constitution
时间窗: Day 0
The presence of atopic stigmata will be clinically assessed by study doctors by using a structured form
Gut microbiome (microbial colonization of the gut)
时间窗: Day 0
Analysis by isolation and sequencing of the microbial DNA
Barrier dysfunction of the skin (Imaging Mass Cytometry)
时间窗: Day 0
Skin biopsies are optional and will be taken from lesional and non-lesional skin
Family history of atopic diseases
时间窗: Day 0
- Assessment of whether parents, siblings or other family members suffer from atopic diseases
Life Quality measured by Dermatology Life Quality Index (DLQI)
时间窗: Day 0
* Min. 0, max. 30 points * Higher scores indicate a lower quality of life
Change of the skin microbiome components over time
时间窗: Day 0 and day 28
* Skin swabs will be taken at the following localizations: Antecubital crease, glabella, vertex, dorsal neck and lesional skin site * Analysis by isolation and sequencing of the microbial DNA
Systemic immune response
时间窗: Day 0
Olink multiplex proteomics analyses and characterization of PBMCs will be performed
Questionnaire about current treatments
时间窗: Day 0
Participants will be asked about their intake of medication and their use of topical treatments
Change of molecular and cellular mediators of the systemic immune response over time
时间窗: Day 0 and day 28
Olink multiplex proteomics analyses and characterization of PBMCs will be performed
次要结局
未报告次要终点
研究者
Marie-Charlotte Brüggen
Principal Investigator
University of Zurich