The suitability of hydrolysed infant formulas was evaluated with four studies in infants and children with milk allergy (n = 20 - 33, median or average age 4.6 months, 31 months, 4.4 years and 29 months). In these children, exposure to cow's milk provoked immediate respiratory, cutaneous or gastrointestinal symptoms 1, 2, 3. One study does not clearly define the sequence and time of symptom emergence 4. Milk and infant formula challenges were carried out in a hospital setting as double-blind placebo-controlled food challenges (DBPCFC) (3 studies) or as a controlled open challenge 3. The formula was administered to the children in increasing doses up to a single dose of 100 - 240 ml either during one day (3 studies, in one of which the administration of the hydrolysate formula was continued freely at home) or over four days 3. In three of the studies the hydrolysed formula was not tolerated by 3 - 13 % of the infants, but was tolerated by all in one of the studies 1.
Comment: The generalisation of the study results should be approached with caution because of the chosen cohorts (only patients with immediate symptoms and only one study included infants) and the methods (the suitability of the formulas in normally used amounts during long-term use was not addressed).
Specific studies: The safety of a hydrolysed infant formula (Alimentum) was studied in 23 children with cow's milk allergy (age 8 months - 9.5 years, median 4.4 years). The cow's milk allergy with immediate respiratory, cutaneous or gastrointestinal symptoms was diagnosed with DBPCFC 1. The safety of the formula was tested in a hospital setting with DBPCFC (10 g of powdered formula in 100 ml of Nutramigen). If the child remained symptom free he/she was given 180 - 240 ml of the product as an open, controlled challenge. All the children tolerated the formula during the hospitalised challenge. Even though the formula was offered for home use after the hospitalised challenge only seven children continued to consume it (median one week).
The safety of two hydrolysed infant formulas (Alimentum, Profylac) and one partially hydrolysed formula (Nidina H.A) was evaluated in 20 children (age 15 - 76 months, median 31 months) with cow's milk allergy. The ingestion of milk provoked immediate respiratory, cutaneous or gastrointestinal symptoms in these children, but all tolerated soya-based formulas 2. DBPCFC was used for the milk and formula challenges, doses were gradually increasing up to 100 ml, and follow-up time was 4 hours. Two of 20 had a positive reaction to Alimentum, 2 of 15 to Profylac and 9 of 20 to Nidina.
The safety of a hydrolysed casein-whey formula (Damira) was studied in 33 infants (age 1.5 - 11 months, median 4.6 months) who suffered from proven cow's milk allergy with immediate respiratory, cutaneous or gastrointestinal symptoms 3. An open, controlled milk challenge was carried out in a hospital setting (n =16). Testing was not carried out in infants with a previous history of a severe reaction to milk and evidence of specific IgE antibodies (n =17). The open, controlled formula challenges were carried out in a hospital setting. The formula was administered to the infant over a period of four days in gradually increasing doses up to a single dose of 100 ml. Administration was then continued freely at home (not controlled). The formula challenge was not carried out in ten infants who were already using it after a diagnosis of cow's milk allergy. Two of 33 had a positive reaction.
The safety of hydrolysed whey formula (Nutrilon Pepti) was compared with another hydrolysed whey-based formula (Profylac) and a partially hydrolysed formula (Nan HA) in 32 infants and children (age 11 - 129 months, median 29 months) with proven cow's milk allergy (DBPCFC) which predominantly manifested itself as urticaria 4. The formula challenge was carried out as a DBPCFC, and the patients were given, in gradually increasing doses, up to 110 ml during the day. If no symptoms were provoked, Nutrilon Pepti was administered openly at home for one week in usually consumed amounts. One of 31 had a positive reaction to Nutrilon pepti, 2 of 25 to Profylac and 9 of 25 to Nan HA.
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