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Safety and Efficacy of a new extensively hydrolyzed formula for infants with Cows’ Milk protein allergy

Cows' Milk Allergy

31/03/2021

Health Professional Looking Through Duo-Scope

Background

Cows’ milk protein allergy (CMPA) is the leading cause of allergy in infants.¹ Previous studies assessing milk formulas with extensively hydrolyzed proteins have reported issues such as reactivity to residual allergens, bitter taste, and the impracticability of adding lactose.^2-8

Objective

In this prospective, controlled food-challenge study, 66 healthy infants (aged <12 months) with CMPA underwent a cows’ milk challenge before randomisation to either double-blind Althéra® followed by amino acid formula (AAF) or the reverse sequence. After completion of this first phase, subjects with no reaction to either formula were re-randomised to open-label Althéra or AAF for 180 days. Outcomes measured include; growth, atopic dermatitis (SCORAD), IgE titres and adverse events (AEs).

Results

During Phase I of the study, no infants demonstrated an allergic reaction to Althéra or the AAF.
Z-scores for length and head circumference were close to 0 during Phase II of the study in both Althéra and the AAF groups, whereas body weight was close to -0.5. There were no significant differences between groups for these measures.
SCORAD scores remained constant in the Althéra group throughout the study Soft stools were significantly more frequent with Althéra than with AAF (66% vs. 47%; p<0.05).
Infants receiving Althéra had significantly fewer incidents of vomiting compared to AAF (3% vs. 27%; p<0.01).
No serious adverse events (AE) were reported in either population.
Good nutritional status was maintained in both groups throughout the study.
Total IgE titres were similar for Althéra and AAF at 90 days.

Discussion

The bitterness of eHFs and AAFs means the addition of lactose may not only increase palatability but also support the absorption of calcium.9,10 Furthermore lactose has been shown to support gut microflora by promoting the growth of bifidobacteria.⁹
Growth (weight, length and head circumference) and symptoms of allergy and tolerability in infants fed eHF were similar to those of infants-fed AAF, a formula considered to be the best treatment for highly sensitive infants.

Using a study format in line with international guidelines the new eHF (Althéra) was demonstrated to be both safe and well tolerated in infants diagnosed with CMPA.

References:

1. Sicherer SH. Food allergy. Lancet 2002: 360: 701–10. 2. Vanderhoof JA, Murray ND, Kaufman SS, et al. Intolerance to protein hydrolysate infant formulas: an underrecognized cause of gastrointestinal symptoms in infants. J Pediatr 1997: 131: 741–4. 3. Hill DJ, Cameron DJ, Francis DE, Gonzalez-Andaya AM, Hosking CS. Challenge confirmation of late-onset reactions to extensively hydrolyzed formulas in infants with multiple food protein intolerance. J Allergy Clin Immunol 1995: 96: 386–94. 4. De Boissieu D, Matarazzo P, Dupont C. Allergy to extensively hydrolyzed cow milk proteins in infants: identification and treatment with an amino acid-based formula. J Pediatr 1997: 131: 744–7. 5. Caffarelli C, Plebani A, Poiesi C, Petroccione T, Spattini A, Cavagni G. Determination of allergenicity to three cows milk hydrolysates and an amino acid derived formula in children with cows milk allergy. Clin Exp Allergy 2002: 32: 74–9. 6. Giampietro PG, Kjellman NI, Oldaeus G, Wouters-Wesseling W, Businco L. Hypoallergenicity of an extensively hydrolyzed whey formula. Pediatr Allergy Immunol 2001: 12: 83–6. 7. Halken S, Host A, Hansen LG, Osterballe O. Safety of a new, ultrafiltrated whey hydrolysate formula in children with cow milk allergy: a clinical investigation. Pediatr Allergy Immunol 1993: 4: 53–9. 8. Sampson HA, Bernhisel-Broadbent J, Yang E, Scanlon SM. Safety of casein hydrolysate formula in children with cow milk allergy. J Pediatr 1991: 118: 520–5. reference 9. Host et al. Dietary products used in infants for treatment and prevention of food allergy. Joint statement of the European Society for Paediatric Allergology and clinical Immunology (ESPACI) Committee on hypoallergenic Formulas and and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition. Arch Dis Chid 1999: 81: 80-4. 10. Ziegler et al. Lactose enhances mineral absorption in infancy. J Pediatr Gastroenterol Nutr 1983: 2: 288-94 .

IMPORTANT NOTICE: Mothers should be encouraged to continue breastfeeding even when their infants have cows’ milk protein allergy. This usually requires qualified dietary counselling to completely exclude all sources of cows’ milk protein from the mothers’ diet. If a decision to use a special formula intended for infants is taken, it is important to give instructions on correct preparation methods, emphasising that unboiled water, unsterilised bottles or incorrect dilution can all lead to illness. Formula for special medical purposes intended for infants must be used under medical supervision.

Cows’ milk protein allergy (CMPA) is the leading cause of allergy in infants. Previous studies assessing milk formulas with extensively hydrolyzed proteins have reported issues such as reactivity to residual allergens, bitter taste, and the impracticability of adding lactose.

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