Growth and tolerance of healthy term infants receiving hydrolyzed infant formulas supplemented with Lactobacillus rhamnosus GG: randomized, double-blind, controlled trial

Abstract

Healthy, term infants received extensively hydrolyzed casein formula (EHF; control), the same formula supplemented with Lactobacillus rhamnosus GG (EHF-LGG), or partially hydrolyzed whey:casein (60:40) formula supplemented with LGG (PHF-LGG), in this double-blind, randomized, controlled, parallel, prospective study. Anthropometric measures and 24-hour dietary and tolerance recalls were obtained at 30, 60, 90, 120, and 150 days of age. Blood collected in a subset of infants was analyzed for fatty acid profiles in plasma and red blood cells and for markers of allergic sensitization. Adverse events were recorded throughout the study. Growth rates were not statistically different between EHF and PHF-LGG and between EHF and EHF-LGG from day 14 to day 30, 120, or 150. No relevant differences in formula tolerance, adverse events, or allergic and immune markers were demonstrated between groups. The extensively and partially hydrolyzed formulas supplemented with LGG support normal growth in healthy, term infants and are well tolerated and safe.

Trial registration: ClinicalTrials.gov NCT00655720.