ABSTRACT
"Objectives: To compare the growth of HIV-exposed uninfected infants fed a biologically acidified milk formula with or without probiotics (Bifidobacterium lactis) during the first six months of life; with control infants fed a standard starter formula.Design: Multi-centre; double-blinded randomised controlled trial.Setting: Infants born to HIV-infected women delivering at one of three academic hospitals in Johannesburg; South Africa.Subjects: Consenting HIV-positive women; who had previously decided not to breast-feed; were randomised to receive one of three milk formulas for their newborn infants.Outcome measures: Comparisons of growth parameters through the first four months of life were made between infants fed the acidified formula without probiotics and those fed the control formula (""acidification effect""); and between infants fed the acidified formulas with and without added probiotics (""probiotic effect"").Results: Of 131 randomised infants; 33 (25) did not complete the study and 13 (10) were HIV infected; leaving 85 infants available for analysis. Infants receiving the acidified formula with probiotics had more rapid head growth (p=0.04) and showed a trend towards more rapid weight gain (p=0.06) over the first four months of life than the infants receiving the acidified formula without probiotics.No other significant differences between the feeding groups were demonstrated.Conclusions: Infants in all study groups grew well; with increased head growth and a trend towards increased weight gain for those receiving probiotics.There were no differences in morbidity between the three study groups and no evidence of adverse effects of the study formulas."