Effects of Infant Formula With Human Milk Oligosaccharides on Growth and Morbidity: A Randomized Multicenter Trial

Study answer

What this study found

The supplemented formula supported normal, age-appropriate growth and was safe and well-tolerated, but it did not improve the primary growth endpoint versus standard formula. In the per-protocol analysis, weight gain from 0 to 4 months was 29.84 vs 30.15 g/day, with a difference of -0.30 (-1.94, 1.34) g/day; the ITT analysis was similarly null at -0.13 (-1.63, 1.37) g/day. Anthropometrics and z-scores were not significantly different at any visit. Secondary findings favored the supplemented formula for some tolerance and morbidity outcomes, including lower bronchitis rates (for example, 0 to…

Study & population

Randomized multicenter trial in healthy term infants who were exclusively formula-fed at enrollment, conducted at two European centers in Belgium and Italy.

Intervention

The active formula contained human milk oligosaccharides 2'FL and LNnT at 1.0 g/L and 0.5 g/L, respectively, in reconstituted cow's milk-based infant formula.

Key limitation

The primary growth outcome was neutral, and the morbidity and tolerance findings were secondary and should be interpreted cautiously.

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Original abstract