title: New validated recipes for double-blind placebo-controlled low-dose food challenges.
abstract: Double-blind placebo-controlled food challenges are considered the most reliable method to diagnose or rule out food allergy. Despite this, there are few validated challenge recipes available. The present study aimed to validate new recipes for low-dose double-blind placebo-controlled food challenges in school children, by investigating whether there were any sensory differences between the active materials containing cow's milk, hen's egg, soy, wheat or cod, and the placebo materials. The challenge materials contained the same hypoallergenic amino acid-based product, with or without added food allergens. The test panels consisted of 275 school children, aged 8-10 and 14-15 yr, respectively, from five Swedish schools. Each participant tested at least one recipe. Standardized blinded triangle tests were performed to investigate whether any sensory differences could be detected between the active and placebo materials. In our final recipes, no significant differences could be detected between the active and placebo materials for any challenge food (p > 0.05). These results remained after stratification for age and gender. The taste of challenge materials was acceptable, and no unfavourable side effects related to test materials were observed. In summary, these new validated recipes for low-dose double-blinded food challenges contain common allergenic foods in childhood; cow's milk, hen's egg, soy, wheat and cod. All test materials contain the same liquid vehicle, which facilitates preparation and dosing. Our validated recipes increase the range of available recipes, and as they are easily prepared and dosed, they may facilitate the use of double-blind placebo-controlled food challenges in daily clinical practice.
authors.affiliation: Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.
authors.forename: Anna
authors.initials: A
authors.lastname: Winberg
authors.forename: Lisbeth
authors.initials: L
authors.lastname: Nordström
authors.forename: Åsa
authors.initials: Å
authors.lastname: Strinnholm
authors.forename: Annica
authors.initials: A
authors.lastname: Nylander
authors.forename: Anette
authors.initials: A
authors.lastname: Jonsäll
authors.forename: Eva
authors.initials: E
authors.lastname: Rönmark
authors.forename: Christina E
authors.initials: CE
authors.lastname: West
mesh_terms: D000293:Adolescent; D000485:Allergens / Q000009:adverse effects / Q000276:immunology; D002648:Child; D004311:Double-Blind Method; D005260:Female; D005502:Food / Q000009:adverse effects / Q000592:standards; D005512:Food Hypersensitivity / Q000175:diagnosis* / Q000276:immunology; D006801:Humans; D007114:Immunization / Q000379:methods* / Q000592:standards; D008297:Male; D015990:Placebo Effect; D017410:Practice Guidelines as Topic; D013548:Sweden
chemical_list: D000485:Allergens