Safety of a new extensively hydrolysed formula in children with cow's milk protein allergy: a double blind crossover study
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Suzanne W J Terheggen-Lagro1, Ilse M S L Khouw, Anne Schaafsma
1Department of Pediatrics, Wilhelmina Children's Hospital, Utrecht, The Netherlands. s.terheggen@wkz.azu.nl
Insights
A new extensively hydrolyzed casein formula (FAC) is safe for children with IgE-mediated cow's milk allergy (CMA). This study confirmed its tolerance and lack of adverse reactions in pediatric patients with persistent CMA.
Area of Science:
- Pediatric Allergy and Immunology
- Clinical Nutrition
- Food Science
Background:
- Infant formulas for cow's milk protein allergy (CMA) typically use extensively hydrolyzed protein, but 'extensively' lacks a precise definition.
- Variations in molecular weight and peptide chain length of hydrolyzed proteins may influence clinical outcomes in CMA.
- This study investigated the safety of a novel extensively hydrolyzed casein-based formula (Frisolac Allergycare: FAC) in children diagnosed with IgE-mediated CMA.
Purpose of the Study:
- To evaluate the safety and tolerance of a new extensively hydrolyzed casein-based infant formula (FAC).
- To compare the physicochemical properties (molecular weight, peptide distribution) of FAC with a reference extensively hydrolyzed formula (Nutramigen: NUT).
- To assess the clinical outcome of using FAC in children with confirmed IgE-mediated cow's milk allergy.
Main Methods:
- A double-blind, randomized crossover study involving 30 children (1.5-14.8 years) with persistent IgE-mediated CMA.
- Participants underwent two 2-week crossover periods, consuming either FAC or NUT (reference product) in combination with an 80% elementary formula base.
- Physicochemical analyses, including molecular weight determination (MALDI-TOF, HPLC) and peptide chain length distribution (Edman degradation), were performed on both formulas.
Main Results:
- Maximum molecular weights were 2.1 kDa for NUT and 2.56 kDa for FAC.
- Free amino acids and peptides <0.5 kDa constituted 46% of FAC's protein fraction and 53% of NUT's.
- Approximately 50% of the protein in both formulas consisted of peptides longer than four amino acids; all children tolerated FAC well with no adverse events reported.
Conclusions:
- The new extensively hydrolyzed casein-based formula (FAC) demonstrates excellent tolerance in children with IgE-mediated CMA.
- Physicochemical characteristics of FAC are comparable to established extensively hydrolyzed formulas.
- FAC is a safe and viable alternative for managing IgE-mediated cow's milk allergy in pediatric populations.
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.
