Assessment of the safety, tolerance, and protective effect against diarrhea of infant formulas containing mixtures of probiotics or probiotics and prebiotics in a randomized controlled trial.

BACKGROUND

Probiotics and prebiotics are considered to be beneficial to the gastrointestinal health of infants.

OBJECTIVE

The objective was to evaluate infant formulas containing probiotics and synbiotics (combinations of probiotics and prebiotics) for safety and tolerance.

DESIGN

In a prospective, controlled, double-blind, randomized trial, healthy full-term infants were exclusively fed a control formula or study formulas containing Bifidobacterium longum BL999 (BL999) + Lactobacillus rhamnosus LPR (LPR), BL999 + LPR + 4 g/L of 90% galactooligosaccharide/10% short-chain fructooligosaccharide (GOS/SCFOS), or BL999 + Lactobacillus paracasei ST11 (ST11) + 4 g/L GOS/SCFOS from < or = 2 to 16 wk of age (treatment period). Safety and tolerance were assessed based on weight gain during the treatment period (primary outcome) as well as recumbent length, head circumference, digestive tolerance, and adverse events (secondary outcomes), which were evaluated at 2, 4, 8, 12, 16, and 52 wk of age.

RESULTS

Two hundred eighty-four infants were enrolled. During the treatment period, difference in mean weight gain between control and study formula groups in both the intention-to-treat and per-protocol populations were within the predefined equivalence boundaries of +/-3.9 g/d, indicating equivalent weight gain. Secondary outcomes did not show significant differences between groups during the treatment period.

CONCLUSION

Infants fed formulas containing probiotics or synbiotics show a similar rate in weight gain compared with those fed a control formula and tolerate these formulas well.