Safety of a new extensively hydrolysed formula in children with cow's milk protein allergy: a double blind crossover study - PubMed (original) (raw)

Clinical Trial

Safety of a new extensively hydrolysed formula in children with cow's milk protein allergy: a double blind crossover study

Suzanne W J Terheggen-Lagro et al. BMC Pediatr. 2002.

Abstract

Background: Formulae for infants with cow's milk protein allergy (CMA) should be based on extensively hydrolysed protein. 'Extensively' however is not strictly defined. Differences in molecular weight and peptide chain length may affect its clinical outcome. We studied the safety of a new extensively hydrolysed casein based formula (Frisolac Allergycare: FAC) for children with IgE mediated CMA.

Methods: Thirty children, aged 1.5 - 14.8 years old (median 4.9 years) with persistent CMA were enrolled in this double-blind reference product (Nutramigen: NUT) controlled crossover study. All had positive skin prick tests (SPT) and IgE mediated allergy, showing immediate reactions after ingestion of small amounts of milk. Twenty-five children also had positive radio allergen sorbent tests (RAST) to cow's milk. Formulae provided consisted of 80% elementary formula in combination with 20% reference or test product. Crossover periods lasted for two weeks. From both products molecular weight (MALDI-TOF method and HPLC) and peptide chain length distribution (adapted Edman degradation) were determined.

Results: Maximum molecular weights of NUT and FAC are 2.1 and 2.56 kDa, respectively. The contribution of free amino acids and small peptides <0.5 kDa is 46% for FAC and 53% for NUT. About 50% of the protein fraction of both products consists of peptides longer than four amino acids. Three children did not complete the study. The other children all tolerated FAC very well; no adverse reactions were reported.

Conclusions: The new extensively hydrolysed casein-based formula (FAC) can safely be used in children with IgE mediated cow's milk allergy.

PubMed Disclaimer

Figures

Figure 1

Figure 1

Molecular weight profile of the hydrolysate used in Frisolac Allergycare® (FAC). The molecular weight profile is determined with the MALDI-TOF method as described by Schols [19] and Kaufmann [15] and Soeryapranata [16].

Figure 2

Figure 2

Molecular weight profile of Nutramigen® (NUT). The molecular weight profile is determined with the MALDI-TOF method as described by Schols [19] and Kaufmann [15] and Soeryapranata [16].

Figure 3

Figure 3

Peptide length profile of the hydrolysate used in Frisiolac Allergycare® (FAC) and Nutramigen® (NUT). The peptide length profile is determined with an adapted Edman degradation method as described by Siemensma et al. [17].

Similar articles

Cited by

References

    1. Taylor SL. Immunologic and allergic properties of cow's milk proteins in humans. J Food Protect. 1986;49:239–250. - PubMed
    1. Exl B-M. A review of recent developments in the use of moderately hydrolyzed whey formulae in infant nutrition. Nutr Res. 2001;21:355–379. doi: 10.1016/S0271-5317(00)00259-1. - DOI
    1. Businco L, Dreborg S, Einarsson R, Giampietro PG, Høst A, Keller KM, Strobel S, Wahn U. Hydrolysed cow's mik formulae. Allergenicity and use in treatment and prevention. An ESPACI position paper. Pediatr Allergy Immunol. 1993;4:101–111. - PubMed
    1. Høst A, Koletzko B, Dreborg S, Muraro A, Wahn U, Aggett P, Bresson J-L, Hernell O, Lafeber H, Michaelsen KF, Michelli J-L, Rigo J, Weaver L, Heymans H, Strobel S, Vandenplas Y. 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 the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition. Arch Dis Child. 1999;81:80–84. - PMC - PubMed
    1. American Academy of Pediatrics Committee on Nutrition: Hypoallergenic infant formulas. Pediatrics. 1989;83:1068–1069. - PubMed

Publication types

MeSH terms

Substances

LinkOut - more resources