Allergy
Conditions
Keywords
double-blind placebo-controlled food challenges, food allergy, food hypersensitivity, triangle test, validated recipes
Brief summary
This study aimed to validate new recipes for cow's milk, hen's egg, soy, cod and wheat, to be used in blinded low-dose food challenges.
Interventions
OTHERElemental E028 with added food allergens
Test materials containing liquid vehicle (Elemental E028)with added food allergens (active)
OTHERElemental E028
Elemental E028 with no added food allergens
Sponsors
The Västerbotten county council
State Government founding for Health Care research
Oskarsfonden
Nutricia, Inc.
Christina West
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Children belonging to one of two age groups: 7-8 years or 14-15 years * No previous hypersensitivity reaction to the food to be tested * Capacity to understand the test instructions and to participate in the test sessions
Exclusion criteria
* Children not belonging to one of the two age groups: 7-8 years or 14-15 years * One or more previous hypersensitivity reaction to the food to be tested * Unability to understand the test instructions and to participate in the test sessions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants detecting sensorial differences between the active materials (containing the allergens cow's milk, hen's egg, soy, wheat or cod) and the placebo materials | — | The present study aimed to validate new recipes for low-dose double-blind placebo-controlled food challenges in school children, by assessing that no sensory differences between the active materials containing cow's milk, hen's egg, soy, wheat or cod, and the placebo materials could be detected by test panels. |
Countries
Sweden
Outcome results
None listed