Objective: To systematically review randomized controlled trials evaluating the efficacy and safety of prebiotic supplementation in full-term neonates. Data Sources: Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and CINAHL databases and proceedings of relevant conferences. Study Selection: Eleven of 24 identified trials (n=1459) were eligible for inclusion. Intervention: Trials comparing formula milk supplemented with or without prebiotics, commenced at or before age 28 days and continued for 2 weeks or longer. Main Outcome Measures: Stool colony counts (bifidobacteria, lactobacilli, and pathogens), pH, consistency, frequency, anthropometry, and symptoms of intolerance. Results: Six trials reported significant increases and 2 reported a trend toward increases in bifidobacteria counts after supplementation. Meta-analysis estimated signifi