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Food Allergy in the Brain

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 8 Years - 15 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - • 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.

Exclusion Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05839405
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

King's College London
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy, Food Allergy in Children, Anxiety, Cognitive Symptom
Additional Details

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.

Arms & Interventions

Arms

: Non Allergic

Recruited patients whose medical records indicate they are not allergic to the foods they were in clinic for

: 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

: 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

Interventions

Other: - None - Cross Sectional.

There is no intervention, this is cross-sectional only.

Contact a Trial Team

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International Sites

St Thomas Hospital, London, United Kingdom

Status

Recruiting

Address

St Thomas Hospital

London, , SE1 7EH

Site Contact

Alexandra Santos, PhD

alexandra.santos@kcl.ac.uk

+44 (0) 20 7188 6424

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