Evaluation of an extensively hydrolysed casein formula (Damira 2000®) in children with allergy to cow's milk proteins

Abstract

The new extensively hydrolysed casein product is safe and well tolerated by most children with ACMP. However, as with other extensive hydrolysates, some highly sensitised patients may present clinical manifestations. Controlled tolerance testing is therefore advised, under specialised medical supervision.

A Double-Blind, Randomized, Crossover Allergy Study of an Extensively Hydrolyzed Casein Formula

“…The PP population included one subject in each group who failed to react to the first challenge to hydrolysate but reacted to the second challenge. Thus, despite efforts to make identical formulations using similar hydrolysates, there remain subtle differences in formulation [9]. G19 could be useful for the subset of subjects who do not tolerate Nutramigen ® and vice versa.…”

“…Burks et al [8] had only 32 subjects per group in a comparison of an amino acid formulation to a commercially available EHC formula; Martin-Esteban et al [18] studied 34 subjects. Because a difference in reactivity of only one or two subjects can change the conclusion about hypoallergenicity [18], larger studies mainly from Europe [9,16,19,20] are more reliable. Our study, with others testing the same hydolysate [19][20][21] provide a solid foundation for use of G19 in CMA.…”

“…CMA was confirmed using criteria previously reported [8,9]. Any of four manners of confirming CMA was sufficient for inclusion: These criteria were not all stated at study initiation and were modified twice by protocol amendments.…”

“…Baseline ImmunoCAP ® test results are shown in Table 2, separated for inspection into age groups under and over 1 year, because milk allergy presents by 1 year of age [5]. Average and median values for total milk IgE and for IgE specific for each of four milk proteins were "high positive" (3.5 to 17.5 kUA/l) or positive very high" (above 17.5 kUA/l) according to criteria used by Ibero et al [9] and were comparable between groups (overall scores). Among individual milk proteins, IgE to casein gave the highest mean and median values.…”

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“…One of the safety requirements of eHFs is that they must be tolerated by at least 90% of children with proven CMA with a 95% confidence interval [5]. Many commercial available hydrolysates for CMA management, either whey-based [13][14][15][16][17][18][19], casein-based [19,20] or a mixture of whey/ casein [19,21] are found suitable for consumption by CMA infants and meet the requirements set out in European and international guidelines.…”