Background and aims Formula containing increased sn-2 palmitate with oligofructose (sn-2+OF) may improve stool consistency. We hypothesised that hard and watery stool incidence among infants fed α-lactalbumin-enriched formula with sn-2+OF would be ≤2.5% (upper limit of 80% CI < 5.0%).
Methods Healthy term infants (n = 440) aged ~42 days were enrolled in this 48-day study on their current feeding regimens: formula-fed (n = 142), HM-fed (n = 143), or mixed-fed (n = 155). Stool consistency was assessed at 4 visits using a 3-day diary with validated 5-point scale (1 = watery, 5 = hard). Gastrointestinal (GI) tolerance was assessed using a validated questionnaire (score range = 13–65; lower values indicate better tolerance).
Results Incidence of hard stools across visits ranged from 0.7% [80% CI: 0.1–2.7] to 2.1% [0.8–4.6] for formula-fed infants, with incidence rates ≤0.8% in mixed-fed, and no hard stools reported in HM-fed groups. Incidence of watery stools ranged from 2.8% [1.2–5.4] to 5.0% [2.8–8.3] for formula-fed infants, which was lower than the incidence rates for mixed-fed (≤8.2%) and HM-fed (≤16.3%) groups. Stool consistency score (2 = runny, 3 = mushy soft) of formula-fed infants (2.9) was higher than HM-fed infants (2.4–2.5; p
Conclusions Formula with sn-2+OF fed to Chinese infants results in soft stools and low incidence of hard and watery stools. Low GI tolerance scores indicate the formula is well tolerated.