(LB03-07-24) Partially Hydrolyzed Cow’s Milk Protein Formula With an Added Prebiotic Blend Reduces Fussiness, Gassiness, Spit-Up, and Crying in Infants With Perceived Fussiness

Objectives: Partially hydrolyzed cow’s milk protein (PHP) formulas have a high-quality protein composition, are nutritionally complete, and have an extensive history of safe use and tolerance in healthy term infants. The current study evaluated the nutritive effects of a PHP formula with an added prebiotic blend in a population of infants with perceived fussiness.

Methods: Infants (15-75 days of age) exclusively receiving a commercial intact protein infant formula and rated moderately, very, or extremely fussy (2, 3, or 4 on 0-4 parental scale) were randomized to: intact cow’s milk protein formula (Control, n=73) or investigational PHP formula (INV-PHP, n=76) over a 28-day period. Both formulas had docosahexaenoic acid (23mg) and arachidonic acid (29mg) per 100 kcal and an added prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) (1:1, 4 g/L). Parents reported infant fussiness, crying (h), gassiness (1-4 scale), spit-ups, and stool consistency (0-5 scale) at baseline (D0), end of study feeding day one (D1), and daily over the feeding period. Data were analyzed using repeated measures ANOVA.

Results: Of 149 infants randomized, 127 completed 28-day study feeding (Control, n=65; INV-PHP, n=62). Mean (±SE) days of age by group was similar (Control: 40.4±2.1; INV-PHP: 42.6±2.1) at D1. Parent-reported mean fussiness, gassiness, and spit-up significantly decreased from D0 to D1(P < 0.001) and from D0 through study end (Wk 4) within each group (P < 0.001). Stool consistency was similar between groups at D0 and remained similar (Wk1-4). For INV-PHP, from D0, crying decreased by D1 (3.4±0.3 vs 3.0±0.3h; P=0.088), was significantly lower by D2 (2.4±0.3h; P< 0.001), and remained significantly lower by D7 (2.1±0.3h; P< 0.001). Although group differences in crying during D0 through D7 were not significantly different (P=0.052); crying was significantly lower across the study period (Wk1-4; P=0.009) for INV-PHP vs Control. In addition, the percentage of participants who cried ≥3 h/day for ≥3 days/week was significantly lower for INV-PHP vs Control (Wk 1, 2, 4; P≤0.045).

Conclusions: In infants with parent-perceived fussiness, a partially hydrolyzed cow’s milk protein formula with an added prebiotic blend effectively reduced infant fussiness, gassiness, spit-up, and crying.

Funding Sources: The study was funded by the study sponsor, Reckitt/Mead Johnson Nutrition.