None listed
Conditions
Brief summary
The study will evaluate a new skin test device used for the diagnosis of cows’ milk or wheat protein intolerance. Diallertest® is a new type of allergy skin test designed for topical application (‘patch test’). Whereas standard allergy tests (‘skin prick tests’) measure immediate (IgE mediated) immune reactions to food and other allergens, the Diallertest® is intended to measure delayed (T cell mediated) reactions occurring 24-72 hours after exposure. Most participants will be recruited from amongst children who have been previously seen at the Allergy Unit and participated in a study of diet and nutrition in children with and without Autistic Spectrum Disorder (X03-0197). Some will be newly recruited from amongst those routinely attending the RPAH Allergy Unit for investigation of symptoms suggestive of non-IgE mediated food intolerances. Children with documented IgE mediated allergies to milk or wheat will be excluded. In order to determine the diagnostic predictive value of Diallertest® in this population, patch test results will be correlated with clinical history, skin prick test results, and oral food challenge results which have been done as part of clinical management. The results may also provide clues as to the mechanisms underlying intolerances to milk and wheat proteins observed in suitably selected children with and without ASD. The feasibility of using digital photography as a means of measuring and recording positive test results will also be evaluated.
Interventions
Diallertest® allergy patch tests. Three Diallertest® patches will be applied to the skin on the child’s back: one with milk protein, one with wheat protein and a ‘control’ patch with no allergen. The patch will be removed at 48 hours and the site of application examined 24 hours later to record any reaction. A positive reaction consists of a 1-2 cm area of localized redness at the contact site. No itch, pain or discomfort should occur.
Sponsors
Diallertest devices supplied as donation by Nutricia Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
3 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Most participants will be recruited from amongst children who have been previously seen at the Allergy Unit and participated in a study of diet and nutrition in children with and without Autistic Spectrum Disorder (X03-0197). Some will be newly recruited from amongst those routinely attending the RPAH Allergy Unit for investigation of symptoms suggestive of non-IgE mediated food intolerances.
Exclusion criteria
Children with documented IgE mediated allergies to milk or wheat will be excluded.
Outcome results
None listed