Partially hydrolysed, prebiotic supplemented whey formula for the prevention of allergic manifestations in high risk infants: a multicentre double-blind randomised controlled trial

In the KGI, AD developed in 93/324 (29%) infants randomised to control and 84/293
(29%) to active (OR 0.94 – [95%CI 0.65-1.36]). We found no difference in AM at 3-5
years. The active group had lower serum cow’s milk (CM) IgG1 at 6 months than the
control (p0.0001) and this difference was still observed at 3 years (p=0.007). Higher
CM-IgG1 levels at 6 months were significantly associated with development of specific
IgE (CM, hen’s egg) at 3 years (p0.05). We found no difference between groups in
adverse events.

Post-hoc analyses were performed on infants who had not introduced solids 18 weeks
(n=312). In this subgroup, active formula was associated with reduced AM at 3-5 years
(n=144; p=0.0334) and lower levels of total-IgE and hen’s egg IgE at 6 months (n=239,
p=0.0092 and n=244, p=0.0061) compared with control group.