Food Allergy
Conditions
Keywords
Food allergy, Diagnosis
Brief summary
The investigators will conduct low-dose intranasal allergen challenges on children/adolescents with a diagnosis of food allergy to egg/cow's milk/soya/wheat/peanut. The data will be used to determine the safety and potential utility of intranasal food challenges in the diagnosis of food allergy.
Interventions
OTHERIntranasal challenge with active substance (food protein)
OTHERIntranasal challenge with placebo
Sponsors
National Institute for Health Research, United Kingdom
Imperial College London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Aged 6 - 17 years old * Physician-diagnosis of food allergy on the basis of: * Positive oral food challenge to the causative food (conducted under medical supervision) within the last 12 months; OR * History of convincing clinical reaction to the causative food within the last 12 months AND positive skin prick test within last 12 months; OR * Evidence of \>95% likelihood of food allergy (on the basis of serum specific IgE or skin prick test (SPT) 8mm or above to the causative food allergen within past 12 months * Written informed consent from parent/guardian, with assent from children aged 8 years and above wherever possible. Participants aged over 16 years will need to provide their owned informed consent.
Exclusion criteria
* Contraindicated as acutely unwell or current unstable asthma: * Acute wheeze in last 72 hours requiring treatment * Febrile ≥38.0oC in last 72 hours * Recent admission to hospital in last 2 weeks for acute asthma * Current medication * Use of asthma reliever medication in last 72 hours * Recent administration of a medication containing antihistamine within the last 4 days * Current oral steroid for asthma exacerbation or course completed within last 2 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiological response to intranasal challenge with a food protein | 20mins | The physiological response to food (egg/cow's milk/soya/wheat/peanut) protein when administered into the human nasal airway in food-allergic children with the corresponding food allergy. This will be assessed objectively (using acoustic rhinometry and peak nasal inspiratory flow) as well as subjectively (using a validated Symptom Scoring questionnaire). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intranasal threshold to food protein | 20 mins | The intranasal threshold to food (egg/cow's milk/soya/wheat/peanut) protein to elicit a local physiological response in food-allergic children (with the corresponding food allergy), as defined by objective assessment described above. |
Countries
United Kingdom
Outcome results
None listed