Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2023-09-29
2025-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Non Allergic
Recruited patients whose medical records indicate they are not allergic to the foods they were in clinic for
None - Cross Sectional.
There is no intervention, this is cross-sectional only.
Mild Allergic
Recruited patients whose medical records indicate they are allergic to the foods they were in clinic for, but only to a mild degree where they would be expected to experience mild, non-life threatening symptoms on exposure to the allergen
None - Cross Sectional.
There is no intervention, this is cross-sectional only.
Severe Allergic
Recruited patients whose medical records indicate they are allergic to the foods they were in clinic for, to a severe degree where they would be expected to experience severe symptoms on exposure to the allergen
None - Cross Sectional.
There is no intervention, this is cross-sectional only.
Interventions
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None - Cross Sectional.
There is no intervention, this is cross-sectional only.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Undergoing any allergen-specific immunotherapy or other immunomodulatory treatments such as biologics and immunosuppressants
8 Years
15 Years
ALL
No
Sponsors
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Guy's and St Thomas' NHS Foundation Trust
OTHER
King's College London
OTHER
Responsible Party
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Locations
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St Thomas Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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322589
Identifier Type: -
Identifier Source: org_study_id
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