Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Number of DAPI-positive cells by allergic group |
After exposure to patient serum, the number of DAPI-positive cells will be measured in the in vitro assay will be measured |
Throughout study, on average 2.5 years |
|
| Primary |
%Ki67-positive cells by allergic group |
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. |
Throughout study, on average 2.5 years |
|
| Primary |
%CC3-positive cells by allergic group |
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. |
Throughout study, on average 2.5 years |
|
| Primary |
%Nestin-positive cells by allergic group |
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. |
Throughout study, on average 2.5 years |
|
| Primary |
%SOX2-positive cells by allergic group |
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. |
Throughout study, on average 2.5 years |
|
| Primary |
%MAP2-positive cells by allergic group |
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. |
Throughout study, on average 2.5 years |
|
| Primary |
%DCX-positive cells by allergic group |
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. |
Throughout study, on average 2.5 years |
|
| Secondary |
General anxiety levels of children by their allergic status, using the Spence's Children's Anxiety Scale |
To determine whether food allergy is associated with changes to general anxiety in children. General anxiety levels will be assessed using the Spence's Children's Anxiety Scale, which has a minimum value of 0 and a maximum value of 114, with higher scores indicating higher levels of anxiety. Mean anxiety scores will be compared across allergic groups. |
Throughout study, on average 2.5 years |
|
| Secondary |
General anxiety levels of parents by their child's allergic status, using the Hospital Anxiety Depression Scale |
To determine whether food allergy is associated with changes to general anxiety in the legal caregiver. General anxiety levels will be assessed using the Hospital Anxiety Depression Scale, which has a minimum limit of 0 and a maximum limit of 21 for anxiety, with a higher score representing higher levels of anxiety. Mean anxiety scores will be compared across allergic groups. Mean anxiety scores will be compared across allergic groups. |
Throughout study, on average 2.5 years |
|
| Secondary |
Food allergy-specific anxiety levels of children by their allergic status, using the Worry About Food Allergy scale |
To determine whether food allergy is associated with changes to food allergy-specific anxiety in children. Food allergy-specific anxiety levels in children will be assessed using the Worry About Food Allergy Child (8-12yrs) and Teen scales (13+yrs). The 8-12yrs variant has a minimum score of 0 and a maximum score of 80. The 13+yrs variant has a minimum score of 0 and a maximum score of 88. Mean anxiety scores will be compared across allergic groups. |
Throughout study, on average 2.5 years |
|
| Secondary |
Food-allergy specific anxiety levels of parents by their child's allergic status, using the Worry About Food Allergy scale |
To determine whether food allergy is associated with changes to food allergy-specific anxiety in the legal caregiver. Food allergy-specific anxiety levels in parents will be assessed using the Worry About Food Allergy Parent scale, which has two variants based on age: one for parents of children aged 8-12yrs and one for parents of children aged 13+yrs. The 8-12yrs variant has a minimum score of 0 and a maximum score of 96. The 13+yrs variant has a minimum score of 0 and a maximum score of 108. Mean anxiety scores will be compared across allergic groups. |
Throughout study, on average 2.5 years |
|
| Secondary |
Cognitive performance by allergic status, using the Mnemonic Similarity Task |
To determine whether food allergy is associated with changes to cognition in children. Cognition will be measured using the Mnemonic Similarity Task, which assesses a specific form of memory called pattern separation. In this task, participants are assessed on their ability to distinguish 'lure' images (images that are similar but different to images seen in the initial phase) from 'old' images (images that are exactly the same as seen in the initial phase). This ability is recorded as the "Lure Discrimination Index", given on a scale of 0-1, with a higher score indicating great cognitive performance. |
Throughout study, on average 2.5 years |
|
| Secondary |
General anxiety levels by hippocampal neurogenic dynamics |
To determine whether any observed food allergy-induced changes to hippocampal neurogenesis are linked to changes in general anxiety, as measured by the correlation between mean percentage expression of neurogenic readouts (outlined in Outcomes 1-7) and general anxiety scores (outlined in Outcome 2) |
Throughout study, on average 2.5 years |
|
| Secondary |
Food allergy-specific anxiety by hippocampal neurogenic dynamics |
To determine whether any observed food allergy-induced changes to hippocampal neurogenesis are linked to changes in food allergy-specific anxiety, as measured by the correlation between mean percentage expression of neurogenic readouts (outlined in Outcomes 1-7) and food allergy-specific anxiety scores (outlined in Outcome 4). |
Throughout study, on average 2.5 years |
|
| Secondary |
Cognitive performance by hippocampal neurogenic dynamics |
To determine whether any observed food allergy-induced changes to hippocampal neurogenesis are linked to changes in cognitive function, as measured by the correlation between mean percentage expression of neurogenic readouts (outlined in Outcomes 1-7) and cognition scores (outline in Outcome 6) |
Throughout study, on average 2.5 years |
|
| Secondary |
The association between food allergy diagnosis and Mast Cell Activation (MAT) |
To assess the association between food allergy diagnosis and MAT to specific allergen in this cohort, as measured by mean %CD63 activation of LAD2 mast cells between allergic groups. A higher percentage of %CD63 activation of LAD2 cells indicate a higher allergic response |
Throughout study, on average 2.5 years |
|
| Secondary |
The association between the Mast Cell Activation (MAT) and hippocampal neurogenesis |
Correlation between %CD63 activation with neurogenesis (Outcomes 1-7) |
Throughout study, on average 2.5 years |
|
| Secondary |
The association between hippocampal neurogenesis and general anxiety levels |
Correlation between neurogenesis rates (outcomes 1-7) and general anxiety scores (outcome 2) |
Throughout study, on average 2.5 years |
|
| Secondary |
The association between hippocampal neurogenesis and food allergy-specific anxiety levels |
Correlation between neurogenesis rates (outcomes 1-7) and food allergy-specific anxiety scores (outcome 4) |
Throughout study, on average 2.5 years |
|
| Secondary |
The association between hippocampal neurogenesis and cognitive performance |
Correlation between neurogenesis rates (outcomes 1-7) and cognitive scores (outcome 6) |
Throughout study, on average 2.5 years |
|
| Secondary |
The association between hippocampal neurogenesis and food allergy medical history |
To assess the effect of multiple food allergy diagnoses (reported as a number indicated number of other food allergy diagnoses) on hippocampal neurogenesis (outcomes 1-7) |
Throughout study, on average 2.5 years |
|
| Secondary |
The association between hippocampal neurogenesis and atopic disease diagnoses |
To assess the effect of atopic disease diagnoses (reported as a number indicated number of atopic disease diagnoses) on hippocampal neurogenesis ((outcomes 1-7) |
Throughout study, on average 2.5 years |
|
