Huet F, Abrahamse-Berkeveld M, Tims S, Simeoni U, Beley G, Savagner C, Vandenplas Y, Hourihane J

OBJECTIVE Fermented formulae (FERM) as well as a specific mixture of 90% short-chain galacto-oligosaccharides and 10% long-chain fructo-oligosaccharides (scGOS/lcFOS; 9:1) have a potential beneficial impact on gastrointestinal function and microbiota development in infants. This study assessed the safety and tolerance of the combination of partly fermented infant milk formulae and scGOS/lcFOS compared to either one feature, in healthy term infants.

METHODS 432 infants were enrolled before 28 days of age and followed up to 17 weeks of age and assigned to one of four groups i) formula with scGOS/lcFOS, ii) scGOS/lcFOS + 15% FERM, iii) scGOS/lcFOS + 50% FERM or iv) 50% fermented formula (50% FERM). Primary outcome was daily weight gain during intervention (equivalence criterion: difference in daily weight gain ≤ 3 g/d). Infants' anthropometrics, formula intake, number and type of (serious) adverse events were monitored monthly. Stool samples were collected at baseline and after 17 weeks for analysis of physiological and microbiological parameters.

RESULTS Equivalence of weight gain per day was demonstrated in both the intention-to-treat and per-protocol population, with a mean weight gain (SD) of 29.7 (6.1), 28.2 (4.8), 28.5 (5.0) and 28.7 (5.9) gram/d for the groups i-iv respectively. No differences were observed in other growth parameters, formula intake and the number or severity of adverse events. In all scGOS/lcFOS-containing formulae, a beneficial effect of scGOS/lcFOS was observed, indicated by the lower pH, lower Clostridium difficile levels and higher SIgA levels.

CONCLUSIONS The partly fermented infant milk formulae containing the specific mixture scGOS/lcFOS were well-tolerated and resulted in normal growth in healthy infants.

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