Development and validation of challenge materials for double-blind, placebo-controlled food challenges in children.
BACKGROUND
The use of double-blind, placebo-controlled food challenges (DBPCFCs) is considered the gold standard for the diagnosis of food allergy. Despite this, materials and methods used in DBPCFCs have not been standardized.


OBJECTIVE
The purpose of this study was to develop and validate recipes for use in DBPCFCs in children by using allergenic foods, preferably in their usual edible form.


METHODS
Recipes containing milk, soy, cooked egg, raw whole egg, peanut, hazelnut, and wheat were developed. For each food, placebo and active test food recipes were developed that met the requirements of acceptable taste, allowance of a challenge dose high enough to elicit reactions in an acceptable volume, optimal matrix ingredients, and good matching of sensory properties of placebo and active test food recipes. Validation was conducted on the basis of sensory tests for difference by using the triangle test and the paired comparison test. Recipes were first tested by volunteers from the hospital staff and subsequently by a professional panel of food tasters in a food laboratory designed for sensory testing. Recipes were considered to be validated if no statistically significant differences were found.


RESULTS
Twenty-seven recipes were developed and found to be valid by the volunteer panel. Of these 27 recipes, 17 could be validated by the professional panel.


CONCLUSIONS
Sensory testing with appropriate statistical analysis allows for objective validation of challenge materials. We recommend the use of professional tasters in the setting of a food laboratory for best results.
Vlieg-Boerstra
Berber J
BJ
Department of Allergy, University Hospital, Groningen, The Netherlands.
Bijleveld
Charles M A
CM
van der Heide
Sicco
S
Beusekamp
Berta J
BJ
Wolt-Plompen
Saskia A A
SA
Kukler
Jeanet
J
Brinkman
Joep
J
Duiverman
Eric J
EJ
Dubois
Anthony E J
AE
D000485:Allergens / Q000009:adverse effects*; D000818:Animals; D018849:Controlled Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D003296:Cooking; D004311:Double-Blind Method; D004531:Eggs / Q000009:adverse effects; D005512:Food Hypersensitivity / Q000175:diagnosis* / Q000209:etiology; D005526:Food, Formulated / Q000009:adverse effects*; D006801:Humans; D008892:Milk / Q000009:adverse effects; D009754:Nuts / Q000009:adverse effects; D010919:Placebos; D013649:Taste; D014908:Triticum / Q000009:adverse effects
D000485:Allergens; D010919:Placebos