Hypoallergenicity of an extensively hydrolyzed whey formula

Several different protein hydrolysate-based infant formulas have been promo ted as hypoallergenic and considered suitable for the dietary management of cow's milk allergy (CMA). Accepting that none of the hydrolysate-based pro ducts is completely safe, the American Academy of Pediatrics (AAP) recommen ds that these formulas should be tested in a double-blind placebo-controlle d setting and tolerated by at least 90% of children with proven CMA. In pri nciple, this recommendation is also endorsed by the European Society of Pae diatric Gastroenterology and Nutrition (ESPGAN) and the European Society of Paediatric Allergy and Clinical Immunology (ESPACI). In this two-center st udy, 32 children with proven CMA were tested with the extensive hydrolysate whey formula Nutrilon Pepti, for comparison with Profylac (extensive) and Nan HA (partial) whey hydrolysate products. Skin-prick tests (SPTs) were, r espectively, positive to the three hydrolysate formulas in 19%, 15%, and 32 % of children. After oral challenge it was concluded that 97% (95% CI: 85-1 00%) of the children tolerated Nutrilon Pepti, 94% (95% CI: 75-100%) tolera ted Profylac, and 64% (95% CI: 37-81%) tolerated Nan HA. This study demonst rates that the extensive hydrolysates Nutrilon Pepti and Profylac are well tolerated in a population of children with proven CMA and that both product s can be considered safe for their intended use. This study confirms that a very small number of children react even to extensively hydrolyzed formula s. SPT prior to oral exposure to the hydrolysate-based formulas can indicat e whether a child is at risk of showing reactions to the product. Introduct ion of new products to these children should be carried out under a doctor' s supervision. However, the majority of the SPT-positive children did toler ate the two extensively hydrolyzed whey-based formulas tested.