Single-dose oral challenges to validate eliciting doses in children with cow's milk allergy

Paul J Turner, Yvonne M d'Art, Bettina Duca, Sophia A Chastell, Guadalupe Marco-Martin, Rosialzira N Vera-Berrios, Olaya Alvarez, Raphaëlle Bazire, Pablo Rodríguez Del Río, Marta Vazquez-Ortiz, Joseph L Baumert, Ronald van Ree, Clare E N Mills, Montserrat Fernandez-Rivas, Jonathan O'B Hourihane

Research output: Contribution to journalArticlepeer-review


BACKGROUND: There is increasing interest in the use of eliciting doses (EDs) to inform allergen risk management. The ED can be estimated from the distribution of threshold doses for allergic subjects undergoing food challenges within a specified population. Estimated ED05 values for cow's milk (the dose expected to cause objective allergic symptoms in 5% of the milk-allergic population) range from 0.5 mg to 13.9 mg cow's milk protein. We undertook a single-dose challenge study to validate a predicted ED05 for cow's milk of 0.5 mg protein.

METHODS: Participants were recruited from 4 clinical centres. Predetermined criteria were used to identify patients reacting to 0.5 mg cow's milk protein (approximately 0.015 mL of fresh cow's milk). Children over 1 year underwent formal challenge to cow's milk to confirm clinical reactivity.

RESULTS: 172 children (median age 6.0 (IQR 0.7-11) years, 57% male) were included in this analysis. Twelve (7.0%, 95% CI 3.7%-11.9%) children experienced objective symptoms that met the predetermined criteria. One participant had mild anaphylaxis that responded to a single dose of adrenaline, the remainder experienced only mild symptoms with no treatment required. We did not identify any baseline predictors of sensitization that were associated with objective reactivity to the single-dose challenge using 0.5 mg cow's milk protein.

CONCLUSIONS: These data support an estimated ED05 for cow's milk of 0.5 mg protein. Values for ED05 above 0.5 mg for cow's milk protein proposed for allergen risk management need to be reviewed.

Original languageEnglish
JournalPediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology
Early online date20 Feb 2021
Publication statusPublished - 13 Mar 2021


  • Voluntary Incidental Trace Allergen Labelling (VITAL)
  • cow's milk
  • eliciting dose
  • single-dose challenge
  • thresholds


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