Food AllergyFABNCT05839405
Food Allergy in the Brain
An observational study of Food Allergy and Food Allergy in Children, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Food Allergy, Food Allergy in Children, Anxiety
- What is being tested?
- None - Cross Sectional.
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Sep 2023to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- • 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Thomas Hospital
London, SE1 7EH
Alexandra Santos, PhD, +44 (0) 20 7188 6424, alexandra.santos@kcl.ac.uk
About this study
Official title: Food Allergy in the Brain: Investigating the Impact of Food Allergy on Children's Mental Health and Cognition, and the Associated Neurobiological Mechanisms
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.
Read the detailed description
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.
- Conditions
- Food Allergy, Food Allergy in Children, Anxiety, Cognitive Symptom
- Being tested
- None - Cross Sectional.
- Medical subject headings
- Food Hypersensitivity, Anxiety Disorders, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - Cross Sectional.Other
There is no intervention, this is cross-sectional only.
| Study group | Role | What they receive |
|---|---|---|
| Non Allergic | Recruited patients whose medical records indicate they are not allergic to the foods they were in clinic for Receives: 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 Receives: 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 Receives: Other: None - Cross Sectional. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Throughout study, on average 2.5 years
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.
Measured: 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
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.
Measured: 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
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.
Measured: Throughout study, on average 2.5 years
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.
Measured: Throughout study, on average 2.5 years
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)
Measured: Throughout study, on average 2.5 years
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).
Measured: Throughout study, on average 2.5 years
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)
Measured: Throughout study, on average 2.5 years
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
Measured: Throughout study, on average 2.5 years
The association between the Mast Cell Activation (MAT) and hippocampal neurogenesis
Correlation between %CD63 activation with neurogenesis (Outcomes 1-7)
Measured: Throughout study, on average 2.5 years
The association between hippocampal neurogenesis and general anxiety levels
Correlation between neurogenesis rates (outcomes 1-7) and general anxiety scores (outcome 2)
Measured: Throughout study, on average 2.5 years
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)
Measured: Throughout study, on average 2.5 years
The association between hippocampal neurogenesis and cognitive performance
Correlation between neurogenesis rates (outcomes 1-7) and cognitive scores (outcome 6)
Measured: Throughout study, on average 2.5 years
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)
Measured: Throughout study, on average 2.5 years
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)
Measured: Throughout study, on average 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start29 Sep 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839405
- Sponsor's protocol ID
- 322589
- Acronym
- FAB
- Status last verified
- Feb 2023
- First submitted
- 27 Feb 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Allergy in the Brain: Investigating the Impact of Food Allergy on Children's Mental Health and Cognition, and the Associated Neurobiological Mechanisms
- ClinicalTrials.gov ID
- NCT05839405
- Acronym / sponsor ID
- FAB / 322589
- Conditions
- Food Allergy, Food Allergy in Children, Anxiety, Cognitive Symptom
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non Allergic | – | Other: None - Cross Sectional.Recruited patients whose medical records indicate they are not allergic to the foods they were in clinic for |
| Mild Allergic | – | Other: None - Cross Sectional.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 | – | Other: None - Cross Sectional.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 |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- • Children ≥ 8 years old and <16 years
Key exclusion criteria (2 listed)
- Diagnosed neurological disorders and learning disabilities, including autism spectrum disorder, attention deficit hyperactivity disorder, Down's Syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None - Cross Sectional.There is no intervention, this is cross-sectional only. | Other | Mild Allergic, Non Allergic, Severe Allergic |
Primary outcome
Number of DAPI-positive cells by allergic group
Time frame: 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
%Ki67-positive cells by allergic group
Time frame: 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
Time frame: 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
Time frame: 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.
%SOX2-positive cells by allergic group
Time frame: 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
Time frame: 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.
%DCX-positive cells by allergic group
Time frame: 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.
15 secondary outcomes
General anxiety levels of children by their allergic status, using the Spence's Children's Anxiety Scale
Time frame: Throughout study, on average 2.5 years
General anxiety levels of parents by their child's allergic status, using the Hospital Anxiety Depression Scale
Time frame: 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
Time frame: 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
Time frame: Throughout study, on average 2.5 years
Cognitive performance by allergic status, using the Mnemonic Similarity Task
Time frame: Throughout study, on average 2.5 years
General anxiety levels by hippocampal neurogenic dynamics
Time frame: Throughout study, on average 2.5 years
Food allergy-specific anxiety by hippocampal neurogenic dynamics
Time frame: Throughout study, on average 2.5 years
Cognitive performance by hippocampal neurogenic dynamics
Time frame: Throughout study, on average 2.5 years
The association between food allergy diagnosis and Mast Cell Activation (MAT)
Time frame: Throughout study, on average 2.5 years
The association between the Mast Cell Activation (MAT) and hippocampal neurogenesis
Time frame: Throughout study, on average 2.5 years
The association between hippocampal neurogenesis and general anxiety levels
Time frame: Throughout study, on average 2.5 years
The association between hippocampal neurogenesis and food allergy-specific anxiety levels
Time frame: Throughout study, on average 2.5 years
The association between hippocampal neurogenesis and cognitive performance
Time frame: Throughout study, on average 2.5 years
The association between hippocampal neurogenesis and food allergy medical history
Time frame: Throughout study, on average 2.5 years
The association between hippocampal neurogenesis and atopic disease diagnoses
Time frame: Throughout study, on average 2.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy and Food Allergy in Children, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Santos, PhD (+44 (0) 20 7188 6424, alexandra.santos@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of DAPI-positive cells by allergic group (time frame: Throughout study, on average 2.5 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.