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Double-blind placebo-controlled food challenges in children with alleged cow’s milk allergy: prevention of unnecessary elimination diets and determination of eliciting doses

Wendy M Dambacher1, Ellen HM de Kort1, W Marty Blom2, Geert F Houben2 and Esther de Vries1*

Author Affiliations

1 Department Pediatrics, Jeroen Bosch Hospital, P.O. Box 90153, 5200 ME, `s-Hertogenbosch, The Netherlands

2 TNO, Zeist, The Netherlands

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Nutrition Journal 2013, 12:22  doi:10.1186/1475-2891-12-22

Published: 8 February 2013



Children with cow’s milk allergy (CMA) need a cow’s milk protein (CMP) free diet to prevent allergic reactions. For this, reliable allergy-information on the label of food products is essential to avoid products containing the allergen. On the other hand, both overzealous labeling and misdiagnosis that result in unnecessary elimination diets, can lead to potentially hazardous health situations. Our objective was to evaluate if excluding CMA by double-blind placebo-controlled food challenge (DBPCFC) prevents unnecessary elimination diets in the long term. Secondly, to determine the minimum eliciting dose (MED) for an acute allergic reaction to CMP in DBPCFC positive children.


All children with suspected CMA under our care (Oct’05 - Jun’09) were prospectively enrolled in a DBPCFC. Placebo and verum feedings were administered on two randomly assigned separate days. The MED was determined by noting the ‘lowest observed adverse effect level’ (LOAEL) in DBPCFC-positive children. Based on the outcomes of the DBPCFC a dietary advice was given. Parents were contacted by phone several months later about the diet of their child.


116 children were available for analysis. In 76 children CMA was rejected. In 60 of them CMP was successfully reintroduced, in 2 the parents refused introduction, in another 3 the parents stopped reintroduction. In 9 children CMA symptoms reappeared. In 40 children CMA was confirmed. Infants aged ≤ 12 months in our study group have a higher cumulative distribution of MED than older children.


Excluding CMA by DBPCFC successfully stopped unnecessary elimination diets in the long term in most children. The MEDs form potential useful information for offering dietary advice to patients and their caretakers.

Cow’s milk allergy; Cow’s milk protein; Double-blind placebo-controlled provocation; Milk hypersensitivity; Minimum eliciting dose