Hypoallergenicity of an extensively hydrolyzed whey formula

Abstract

Several different protein hydrolysate-based infant formulas have been promoted as hypoallergenic and considered suitable for the dietary management of cow's milk allergy (CMA). Accepting that none of the hydrolysate-based products is completely safe, the American Academy of Pediatrics (AAP) recommends that these formulas should be tested in a double-blind placebo-controlled setting and tolerated by at least 90% of children with proven CMA. In principle, this recommendation is also endorsed by the European Society of Paediatric Gastroenterology and Nutrition (ESPGAN) and the European Society of Paediatric Allergy and Clinical Immunology (ESPACI). In this two-center study, 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, respectively, positive to the three hydrolysate formulas in 19%, 15%, and 32% of children. After oral challenge it was concluded that 97% (95% CI: 85-100%) of the children tolerated Nutrilon Pepti, 94% (95% CI: 75-100%) tolerated Profylac, and 64% (95% CI: 37-81%) tolerated Nan HA. This study demonstrates that the extensive hydrolysates Nutrilon Pepti and Profylac are well tolerated in a population of children with proven CMA and that both products can be considered safe for their intended use. This study confirms that a very small number of children react even to extensively hydrolyzed formulas. SPT prior to oral exposure to the hydrolysate-based formulas can indicate whether a child is at risk of showing reactions to the product. Introduction of new products to these children should be carried out under a doctor's supervision. However, the majority of the SPT-positive children did tolerate the two extensively hydrolyzed whey-based formulas tested.

Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes

“…The incidence of reported adverse effects in allergic infants fed partially or extensively hydrolysed milk (either casein or whey) formulas in tertiary care centres range around 45 to 65 % and 3 to 6 %, respectively (Giampietro et al, 2001;Caffarelli et al, 2002;Fiocchi et al, 2010).…”

Diagnosis and Management of Cows' Milk Protein Allergy in Infants

“…According to consensus in literature, a therapeutic formula is a formula tolerated by at least 90% (with 95% confidence) of CMPA infants (26,27). Many eHF's based on whey, casein or another protein source comply to those criteria as well as amino acid based formulae (AAF).…”

Has in vitro allergenicity testing any clinical relevance?

“…If this increased incidence and duration of breast feeding is confirmed in other trials, it may be a good reason to recommend dietary intervention in all infants, independent of the presence or absence of any effect on the incidence of cow's milk allergy. It is obvious that the residual allergenicity in partial hydrolysates is too high to administer this kind of formula in children with cow's milk allergy (6). As a consequence, the introduction in the abstract of the paper of Docena et al is somehow misleading, because the authors state that their 'study aimed to investigate the presence of residual allergenic cow's milk proteins in some milk substitutes employed in the treatment of cow's milk allergy' (2).…”

“…Partial hydrolysates are contraindicated in the treatment of cow's milk allergy, as listed on their label. Equally, Giampietro et al (6) correctly wrote that the American Academy of Pediatrics, the ESPGHAN and ESPACI, endorse the statement that partial hydrolysates should not be used in therapeutic conditions. Yet, Giampietro et al challenged cow's milk allergic children with a partial hydrolysate (6).…”

“…However, the majority of allergic children tolerate extensive hydrolysates (5). In a comparative study, 19 and 15% of children had a positive SPT to an extensive hydrolysate, but clinically tolerated the extensive hydrolysate in 97 and 94%, respectively (6). The '100% diagnostic SPT levels' avoids up to 23% of double-blind placebocontrolled food challenges that would have been necessary according to the results of in vitro tests (7).…”