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

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

ERYTHROCYTE AND PLASMA-CHOLESTEROL ESTER LONG-CHAIN POLYUNSATURATED FATTY-ACIDS OF LOW-BIRTH-WEIGHT BABIES FED PRETERM FORMULA WITH AND WITHOUT RIBONUCLEOTIDES - COMPARISON WITH HUMAN-MILK

We investigated whether a regular formula for premature infants (pre) supplemented with ribonucleotides (pre+RN) raises erythrocyte and plasma cholesterol ester (CE) long-chain polyunsaturated fatty acids (LCPUFAs) of low-birthweight babies (less than or equal to 2.50 kg) compared with their breast-fed counterparts. From days 11 to 42, 31 babies received the pre formula and 37 received pre+RN. Eleven breast-fed babies served as a reference group. Erythrocytes and CE fatty acids were determined on days 11, 21, and 42. There were no differences in the courses of erythrocytes and CE fatty acids between pre formula-fed and pre+RN-fed babies. On day 42, formula-fed babies had lower erythrocytes and CE n-3 and n-6 LCPUFAs compared with breast-fed babies. Subdivision into gestational age- and body weight-matched subgroups gave similar results. RN supplementation does not augment the erythrocyte and CE LCPUFA status of formula-fed babies