Prebiotic Supplementation in Full-term Neonates - A Systematic Review of Randomized Controlled Trials

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 significant reduction in stool pH in infants who received prebiotic supplementation (weighted mean difference, -0.65; 95% confidence interval, -0.76 to -0.54; 6 trials). Infants who receive a supplement had slightly better weight gain than did controls (weighted mean difference, 1.07 g; 95% confidence interval, 0.14-1.99; 4 trials) with softer and frequent stools similar to breastfed infants. All but 1 trial reported that prebiotic supplementation was well tolerated. In that trial, diarrhea (18% vs 4%; P=. 008), irritability (16% vs 4%; P=. 03), and eczema (18% vs 7%; P=. 046) were reported more frequently by parents of infants who received prebiotic supplements. Conclusions: Prebiotic-supplemented formula is well tolerated by full-term infants. It increases stool colony counts of bifidobacteria and lactobacilli and results in stools similar to those of breastfed neonates without affecting weight gain. Larger trials with long-term follow-up are needed to determine whether these short-term benefits are sustained.