Evaluation of a formula with low protein content and supplemented with probiotic agents after breast milk weaning

Besides assuring growth and development in early infancy, human breast milk plays a key role in preventing infections, in particular by favouring the growth of bifidobacteria. The development of infant formulas containing probiotic agents consequently represents a significant advance in the provision of an optimal alternative to breast feeding when this is not feasible. A further concern is to avoid an excessively high protein content relative to breast milk, potentially favouring obesity in later life. The objective of this open Multicenter comparative study was to demonstrate that a new infant formula, characterized by a reduced protein content and the presence of a probiotic agent, was as effective as conventional formulas in assuring growth during the first months of life. The study population comprised full-term healthy infants with an age at inclusion of 1-28 days, whose mothers no longer wished to continue breast feeding or were unable to breast feed. The test formula (GE), enriched with Bifidobacterium lactis, had a protein content of 1.5 g/100 ml. The primary end point was daily weight gain from day 0 to day 90. Secondary end points were daily increase in height and cranial circumference, overall and gastrointestinal tolerance and formula acceptability. A total of 203 infants were included in the analysis, 117 receiving GE and 86 the formula habitually prescribed by the paediatrician. Daily gains in weight, height and cranial circumference did not differ significantly between the groups. The rates of overall and gastrointestinal adverse events were comparable in the two groups and the acceptability of GE was consistently good, similar to that of the standard formulas. The results of this study demonstrated that the new probiotic infant formula GE has equivalent efficacy to conventional formulas in achieving growth in early infancy, and is well tolerated.