Gastrointestinal tolerance of a new infant milk formula in healthy babies: an international study conducted in 17 countries.

OBJECTIVE

We tested the hypothesis that the gastrointestinal tolerance of a new infant formula equals or exceeds the tolerance of other milk-based infant formulas and compared the tolerance of this new formula with that of human milk.

METHODS

This prospective, phase IV, open-label study was conducted in 17 countries. Healthy, full-term infants, 28 to 98 d old, were enrolled on their current feeding (no treatment assigned). Feeding regimens included human milk (HM), a new infant formula (NF; Similac Advance), other infant formula (OF), HM + NF, and HM + OF. Data for stool frequency, stool consistency, and gastrointestinal symptoms were collected in study diaries for 2 wk.

RESULTS

Gastrointestinal tolerance was evaluated in 6999 infants: 979 (14.0%) received HM, 1695 (24.2%) received HM + NF, 635 (9.1%) received HM + OF, 2677 (38.2%) received NF, and 1013 (14.5%) received OF. Infants fed HM had softer and more frequent stools than did those who received NF, HM + NF, or OF (P < 0.001). Infants fed NF had softer and more frequent stools than did those fed OF (P < 0.001), including those fed Enfalac or S-26 (P < 0.001). Regurgitation (P < 0.001) and colic (P = 0.006) were more frequent with OF than with NF. All feeding regimens were well tolerated and only 3.5% of subjects experienced adverse events.

CONCLUSIONS

This global study demonstrated that stools of infants fed NF are softer and more frequent than stools from infants fed OF and are closer to those of breast-fed infants. Infants consuming NF also experienced less regurgitation and colic than did infants in other feeding groups.