Safety of supplementing infant formula with long-chain polyunsaturated fatty acids and Bifidobacterium lactis in term infants: a randomised controlled trial.

Probiotics and long-chain PUFA (LC-PUFA) may be beneficial supplements for infants who are not breast-fed. The aim of the present study is to evaluate the safety of an infant formula containing the LC-PUFA DHA and arachidonic acid (AA) and the probiotic Bifidobacterium lactis by comparing the growth rate of infants fed the supplemented and unsupplemented formulas. One hundred and forty-two healthy, term infants were enrolled in a single-centre, randomised, double-blind, controlled, parallel-group trial, and allocated to receive either standard or probiotic and LC-PUFA-containing experimental formulas. The infants were fed with their assigned formulas for 7 months. The primary outcome (weight gain) and the secondary outcomes (length, head circumference and formula tolerance) were measured throughout the study. LC-PUFA status was assessed at 4 months of age and immune response to childhood vaccines was measured at 7 months of age. There was no significant difference in growth between the two groups. The 90 % CI for the difference in mean weight gain was - 0.08, 3.1 g in the intention-to-treat population and 0.1-3.8 g in the per protocol population, which lay within the predefined boundaries of equivalence, - 3.9-3.9. There were no significant differences in mean length and head circumference. DHA and AA concentrations were higher in infants in the experimental formula group compared with the control formula group. No influence of the supplements on the response to vaccines was observed. Growth characteristics of term infants fed the starter formula containing a probiotic and LC-PUFA were similar to standard formula-fed infants.