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

Terheggen-Lagro SW, Khouw IM, Schaafsma A, Wauters EA - BMC Pediatr (2002)

Bottom Line: We studied the safety of a new extensively hydrolysed casein based formula (Frisolac Allergycare: FAC) for children with IgE mediated CMA.Three children did not complete the study.The new extensively hydrolysed casein-based formula (FAC) can safely be used in children with IgE mediated cow's milk allergy.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Pediatrics, Wilhelmina Children's Hospital, Utrecht, The Netherlands. s.terheggen@wkz.azu.nl

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.

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Related in: MedlinePlus

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].
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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].

Mentions: Molecular weight profile and peptide length profile of the hydrolysates are shown in Figures 1, 2 and 3. Figures 1 and 2 show no relevant differences in absolute molecular weight between FAC and NUT. In peptide length profile (Figure 3), the test hydrolysate showed to have more di- and tripeptides and a somewhat lower free amino acid content compared with NUT.


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

Terheggen-Lagro SW, Khouw IM, Schaafsma A, Wauters EA - BMC Pediatr (2002)

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].
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC130212&req=5

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].
Mentions: Molecular weight profile and peptide length profile of the hydrolysates are shown in Figures 1, 2 and 3. Figures 1 and 2 show no relevant differences in absolute molecular weight between FAC and NUT. In peptide length profile (Figure 3), the test hydrolysate showed to have more di- and tripeptides and a somewhat lower free amino acid content compared with NUT.

Bottom Line: We studied the safety of a new extensively hydrolysed casein based formula (Frisolac Allergycare: FAC) for children with IgE mediated CMA.Three children did not complete the study.The new extensively hydrolysed casein-based formula (FAC) can safely be used in children with IgE mediated cow's milk allergy.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Pediatrics, Wilhelmina Children's Hospital, Utrecht, The Netherlands. s.terheggen@wkz.azu.nl

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.

Show MeSH
Related in: MedlinePlus