OP-18 THE COMBINATION OF SCGOS/LCFOS AND FERMENTED INFANT FORMULA SOFTENS STOOLS OF INFANTS COMPARED TO UNFERMENTED INFANT FORMULA WITHOUT SCGOS/LCFOS.

OBJECTIVES AND STUDY: Hard stools can be commonly observed in formula-fed infants, but rarely in breast fed infants. The effects on stool frequency and stool consistency of a novel infant formula were evaluated in a randomized, controlled, double-blind, multicenter, parallel-group, intervention study on gastrointestinal (GI) tolerance. The novel infant formula (FF+) combined fermented formula (Lactofidus™) with short-chain galacto-oligosaccharides and long-chain fructo-oligosaccharides (scGOS/lcFOS, ratio 9:1, 0.8 g/100 ml).

METHODS: Healthy, term infants aged 0-28 days were randomized after parent's autonomous decision to discontinue breastfeeding, to receive either infant formula with scGOS/lcFOS and 30% fermented formula (FF+, n = 95 infants), or infant formula without fermented formula and scGOS/lcFOS (IF-, n = 105 infants). Exclusively breast fed infants (n = 100) were included as a reference group. Parents completed standardized diaries with daily entries on stool consistency and frequency until 17 weeks of age. Stool consistency was rated on a five point scale. Starting at an age of 4 weeks, the distributions of the weekly average of the daily mean stool consistency, and distributions of the daily average number of stools were compared between intervention groups.

RESULTS: Based on low GI symptom-scores and adverse events, the newly-developed infant formula FF+ was well tolerated. The average stool consistency of infants fed with FF+ was closer to the breast fed reference group, and had a significantly softer median stool consistency than IF- fed infants from 4 weeks of age for the remaining study period (Mann Whitney, p ≤ 0.005). From 9 weeks of age, FF+ fed infants had a significantly higher median stool frequency than IF- fed infants (Mann Whitney, p ≤ 0.05).

CONCLUSIONS: The specific combination of 30% fermented formula with scGOS/lcFOS yielded stool consistencies closer to that of breastfed infants, and significantly softer stools than those of infants fed a standard formula.