Food Allergy in the Brain: Investigating the Impact of Food Allergy on Children's Mental Health and Cognition, and the Associated Neurobiological Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- %DCX-positive cells by allergic group
研究概览
简要总结
Preventing food allergic reactions predominantly relies on allergen avoidance and managing this daily causes high anxiety in some patients, while having an allergic reaction can cause a post-traumatic stress disorder-like syndrome in children. The underlying mechanisms of these psychological changes are poorly understood, but one potential mechanism may be post-natal hippocampal neurogenesis (HN). HN is the production of new neurons from stem cells in the hippocampus which is one of the brain centres for memory and mood regulation. HN has been associated with cognitive function and some psychiatric disorders. Importantly, it can be influenced by both internal (bloodstream) and external (exercise, diet, etc.) factors. This study will explore the link between food allergy and children's mental health and cognition, and to determine whether this is linked to changes in HN.
详细描述
Preventing food allergic reactions predominantly relies on allergen avoidance and managing this daily causes high anxiety in some patients, while having an allergic reaction can cause a post-traumatic stress disorder-like syndrome in children. The underlying mechanisms of these psychological changes are poorly understood, but one potential mechanism may be post-natal hippocampal neurogenesis (HN). HN is the production of new neurons from stem cells in the hippocampus which is one of the brain centres for memory and mood regulation. HN has been associated with cognitive function and some psychiatric disorders. Importantly, it can be influenced by both internal (bloodstream) and external (exercise, diet, etc.) factors. This study will explore the link between food allergy and children's mental health and cognition, and to determine whether this is linked to changes in HN.
This study will recruit child patients (aged 8-15 years), and their legal parent/guardian, that are attending a routine clinic appointment at the Paediatric Allergy Unit at St Thomas' Hospital. Parent/guardians and the child will be approached by the patient's direct clinical team, who will explain the study procedures involved in participation. Consented adult (parent/guardian) participants will be asked to complete three anxiety questionnaires, to assess the influence of parental anxiety on that of the child. Consented child participants will be asked to complete two anxiety questionnaires and a memory task. Blood samples from the patient will also be collected in addition to those taken as part of their routine clinic appointment. Specifically, blood will be collected in the following tubes: gold top Vacutainer tube containing clot activator and gel for serum separation (4ml 8-15yrs), green top Vacutainer tube containing lithium heparin for whole blood (4ml 8-15yrs), and blue top Vacutainer tube containing citrate for peripheral blood mononuclear cell (PBMC) and plasma separation and storage (30ml 8-12yrs; 50ml 13-15yrs).
The plasma and serum from this collection will be used on two stem cell models that mimic food allergic reactions and HN, respectively. Any differences in these processes will be analysed alongside the questionnaire and memory task data and, if a link is successfully demonstrated, further work will aim to identify blood-borne factors responsible for these changes. This study will shed light on the impact of food allergy on children's mental health as well as the biological processes behind it.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Children ≥ 8 years old and <16 years
- •Suspected food allergy (non-defined allergen)
- •Undergoing blood collection for IgE testing at their clinic appointment
- •Fluent / age-appropriate level of English (verbal and written) of both the child and legal parent / guardian
排除标准
- •Diagnosed neurological disorders and learning disabilities, including autism spectrum disorder, attention deficit hyperactivity disorder, Down's Syndrome.
- •Undergoing any allergen-specific immunotherapy or other immunomodulatory treatments such as biologics and immunosuppressants
结局指标
主要结局
%DCX-positive cells by allergic group
时间窗: Throughout study, on average 2.5 years
After exposure to patient serum, cells fluorescently expressing DCX will be quantified within a total pool of cells that are fluorescently positive for DAPI (a nuclear DNA stain), i.e., total percentage of double fluorescently labelled cells within a total single (DAPI) stained population.
Number of DAPI-positive cells by allergic group
时间窗: Throughout study, on average 2.5 years
After exposure to patient serum, the number of DAPI-positive cells will be measured in the in vitro assay will be measured
%SOX2-positive cells by allergic group
时间窗: Throughout study, on average 2.5 years
After exposure to patient serum, cells fluorescently expressing SOX2 will be quantified within a total pool of cells that are fluorescently positive for DAPI (a nuclear DNA stain), i.e., total percentage of double fluorescently labelled cells within a total single (DAPI) stained population.
%MAP2-positive cells by allergic group
时间窗: Throughout study, on average 2.5 years
After exposure to patient serum, cells fluorescently expressing MAP2 will be quantified within a total pool of cells that are fluorescently positive for DAPI (a nuclear DNA stain), i.e., total percentage of double fluorescently labelled cells within a total single (DAPI) stained population.
%Ki67-positive cells by allergic group
时间窗: Throughout study, on average 2.5 years
After exposure to patient serum, cells fluorescently expressing Ki67 will be quantified within a total pool of cells that are fluorescently positive for DAPI (a nuclear DNA stain), i.e., total percentage of double fluorescently labelled cells within a total single (DAPI) stained population.
%CC3-positive cells by allergic group
时间窗: Throughout study, on average 2.5 years
After exposure to patient serum, cells fluorescently expressing CC3 will be quantified within a total pool of cells that are fluorescently positive for DAPI (a nuclear DNA stain), i.e., total percentage of double fluorescently labelled cells within a total single (DAPI) stained population.
%Nestin-positive cells by allergic group
时间窗: Throughout study, on average 2.5 years
After exposure to patient serum, cells fluorescently expressing Nestin will be quantified within a total pool of cells that are fluorescently positive for DAPI (a nuclear DNA stain), i.e., total percentage of double fluorescently labelled cells within a total single (DAPI) stained population.
次要结局
- General anxiety levels of children by their allergic status, using the Spence's Children's Anxiety Scale(Throughout study, on average 2.5 years)
- General anxiety levels by hippocampal neurogenic dynamics(Throughout study, on average 2.5 years)
- Cognitive performance by allergic status, using the Mnemonic Similarity Task(Throughout study, on average 2.5 years)
- Food allergy-specific anxiety by hippocampal neurogenic dynamics(Throughout study, on average 2.5 years)
- Cognitive performance by hippocampal neurogenic dynamics(Throughout study, on average 2.5 years)
- The association between food allergy diagnosis and Mast Cell Activation (MAT)(Throughout study, on average 2.5 years)
- General anxiety levels of parents by their child's allergic status, using the Hospital Anxiety Depression Scale(Throughout study, on average 2.5 years)
- Food-allergy specific anxiety levels of parents by their child's allergic status, using the Worry About Food Allergy scale(Throughout study, on average 2.5 years)
- The association between the Mast Cell Activation (MAT) and hippocampal neurogenesis(Throughout study, on average 2.5 years)
- The association between hippocampal neurogenesis and general anxiety levels(Throughout study, on average 2.5 years)
- Food allergy-specific anxiety levels of children by their allergic status, using the Worry About Food Allergy scale(Throughout study, on average 2.5 years)
- The association between hippocampal neurogenesis and cognitive performance(Throughout study, on average 2.5 years)
- The association between hippocampal neurogenesis and food allergy medical history(Throughout study, on average 2.5 years)
- The association between hippocampal neurogenesis and atopic disease diagnoses(Throughout study, on average 2.5 years)
- The association between hippocampal neurogenesis and food allergy-specific anxiety levels(Throughout study, on average 2.5 years)