Food Allergy in the Brain

NCT05839405 | Unknown

• 1 other identifier: 322589
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Food Allergy; Food Allergy in Children; Anxiety; Cognitive Symptom

Outcome Measures

Primary Outcomes (7)

• 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

• %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

• %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

• %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

• %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

• %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

• %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 Outcomes (15)

• 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 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 children by their allergic status, using the Worry About Food Allergy 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

• Cognitive performance by allergic status, using the Mnemonic Similarity Task

  Throughout study, on average 2.5 years

Study Arms (3)

Non Allergic

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

Other: None - Cross Sectional.

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

Other: None - Cross Sectional.

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

Other: None - Cross Sectional.

Interventions

None - Cross Sectional. OTHER

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

Mild Allergic; Non Allergic; Severe Allergic

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

St Thomas Hospital

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity; Anxiety Disorders; Neurobehavioral Manifestations

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexandra Santos, PhD

CONTACT

+44 (0) 20 7188 6424; alexandra.santos@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: May 3, 2023
• Study Start: September 29, 2023
• Primary Completion: September 30, 2025
• Study Completion: October 1, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)