Comment: When the study results are compared with those derived from short-term studies it should be taken into account that in the long-term studies the cohorts are significantly less select and mainly comprise infants. In two of the studies, the majority of the cohort had cutaneous manifestations. The cohorts are also fairly small. The clinical significance of the improved growth rate of the children receiving amino acid-based formulas, as compared with those fed with a hydrolysed formula, in one non-randomised study is not clear.
Specific studies: A study evaluated (by a food challenge and follow-up study) the safety of a whey protein-based hydrolysate infant formula (Profylac) in 66 infants and children, aged between 1 month and 14.5 years, who suffered from cow's milk allergy with respiratory, cutaneous or gastrointestinal symptoms 1. The median age of the infants (n = 15) was 5 months and that of the children (n= 51) 2 and 4/12 years. A randomised control group consisted of 16 infants being fed with Nutramigen (median age 4 months). The challenges were open and controlled elimination-challenge tests, and the follow-up continued for at least 3 months (n = 64, one withdrew due to infection, one moved away from the country) or 6 months (n = 58). The formula was tolerated definitely by 62 of 66; four had an inconclusive reaction. Of the children aged more than 12 months, who continued to consume the formula for at least six months, six consumed approximately 100 ml, one consumed variable amounts and 45 consumed 250 - 750 ml per 24 hours. The formula was suitable for infants in age-related use, and there were no reports of diarrhoea or other gastrointestinal manifestations. Growth patterns were normal.
A randomised, prospective follow-up study (9 months) evaluated the efficacy and safety of a hydrolysed infant formula (Peptidi-Tutteli) and an amino acid-derived formula (Neocate) in infants with cow's milk allergy, which manifested itself as atopic eczema and, in some of the patients, gastrointestinal symptoms 2. The hydrolysed formula was fed to 22 infants (age 4 - 7 months, mean 6 months), and the amino acid-derived formula to 23 infants (age 5 - 8 months, mean 7 months). DBPCFC had been used to diagnose milk allergy. Both products were well tolerated and effective in the treatment of atopic eczema. However, growth was slightly more improved in the amino acid group. According to the researchers an amino acid-derived formula may be preferable for infants with multiple food allergies or growth disturbances.
The efficacy and safety of two hydrolysed whey-based infant formulas (Pepti Junior, Nutrilon Pept, contains lactose) in infants with milk allergy, which manifested itself as respiratory, cutaneous or gastrointestinal symptoms, was evaluated in a prospective study. Forty-six infants received Nutrilon and 33 Pepti Junior 3. The 157 study subjects, aged less than 4 months, originated from 50 Baby Health Clinics. The infants were fed with formula feeds, and all had suspected allergy to milk. Allergy was diagnosed with elimination-challenge testing, the diet during the elimination phase consisting of the formulas to be studied (pseudorandomised groups). The milk challenge was open and allergy was diagnosed in 79 infants. The intervention period lasted for at least 10 weeks. The symptoms improved, the most profound being the decrease in prevalence and severity of eczema, infantile colic and fretfulness. The infants' growth followed their growth curve. No differences in symptoms or growth were found between the two infant formulas.
A prospective, controlled, multicentre study of six months, evaluated the effect of an amino-acid based formula (Neocate), and a whey hydrolysate-based formula (Alfare or Peptidi-Tutteli), on the symptoms and growth of 73 infants (age 1.6 - 9 months, median 5.7 months) with cow's milk allergy and atopic eczema 4. DBPCFC was used to diagnose milk allergy; the majority of the children manifested cutaneous symptoms and a few had gastrointestinal or respiratory symptoms. The cutaneous symptoms improved during the study both in the amino acid group (n = 31) and in the hydrosylate group (n = 42). Moreover, in the amino acid group there was a slight, but clinically significant, increase in the length standard deviation score which improved towards the end of the study period.
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