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A Systematic Review of Randomized Controlled Trials

Shripada Rao, MD, DM, FRACP; Ravisha Srinivasjois, FRACP; Sanjay Patole, DrPH, FRACP

Arch Pediatr Adolesc Med. 2009;163(8):755-764.

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.

Author Affiliations: Departments of Neonatology, King Edward Memorial Hospital for Women (Drs Rao, Srinivasjois, and Patole) and Princess Margaret Hospital for Children (Drs Rao and Srinivasjois), and Women's and Infants' Health, University of Western Australia (Drs Rao and Patole), Perth, Western Australia, Australia.

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