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.
RCT Entities:
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.
Authors: Michael Radke; Jean-Charles Picaud; Andrea Loui; Gilles Cambonie; Dirk Faas; Harry N Lafeber; Nanda de Groot; Sophie S Pecquet; Philippe G Steenhout; Jean-Michel Hascoet Journal: Pediatr Res Date: 2016-12-21 Impact factor: 3.756
Authors: Mary Ellen Sanders; Louis M A Akkermans; Dirk Haller; Cathy Hammerman; James Heimbach; Gabriele Hörmannsperger; Geert Huys; Dan D Levy; Femke Lutgendorff; David Mack; Phoukham Phothirath; Gloria Solano-Aguilar; Elaine Vaughan Journal: Gut Microbes Date: 2010-03-04