(EA03-10-25) Clinically Relevant Outcomes in Infants Fed a Formula Supplemented With Five Specific Human Milk Oligosaccharides: A Large, Randomized, Controlled Trial

Scientific conference where the work was recently presented: NASPGHAN (North American Society for Pediatric Gastroenterology, Hepatology and Nutrition)

Date on which the work was previously presented at the scientific conference listed: November 8, 2024

Objectives: In breast milk, human milk oligosaccharides (HMO) are the 3^rd most predominant solid component. Clinical studies on infant formula have expanded to 5 HMO blends. A scientific research gap is longer-term study of infant formula with HMOs, especially on efficacy.

Methods: The primary outcome of this randomized, controlled trial was no difference in weight-for-age z-scores at 6 months of age among groups. Healthy, term infants were randomized to receive study formula (SF) with 5 HMOs (2.5 g/L: 2′-FL, 3-FL, LNT, 3′-SL, 6′-SL) or a matched control formula (CF) without HMOs. As a reference, a non-randomized human milk (HM)-fed group was also enrolled. Outcomes included growth parameters, parent-reported GI tolerance, infant health, morbidity, and adverse events (AE). Outcomes were analyzed using AN(C)OVA, Wilcoxon rank sum test, negative binomial regression, chi-square, or Fisher exact test. P-values were considered statistically significant with P≤0.05 (SAS® 9.4).

Results: N=607 infants were enrolled from 40 study centers across the US: n=597 infants were ITT and n=387 were protocol evaluable. The primary outcome was achieved. Infants fed SF had significantly lower average mean rank stool consistency than CF at 1 (LSM±SE: 2.09±0.07 vs 2.29±>0.08, P=0.047), 2 (2.07±0.07 vs 2.30±0.07, P=0.013), and 4 (2.38±0.0­­8 vs 2.65±0.08, P=0.004) months of age. Parents reported significantly fewer infants fed SF, compared to CF, had healthcare visits beyond routine well visits (35.7% vs 48.2%, P=0.022) through 4 months of age. During the 6-month clinical study, fewer infants fed SF had parent-perceived illness (47.8% vs 58.3%, P=0.032) compared to CF. In a post hoc analysis of infants with infections, infants fed SF had a significantly shorter duration of infection AEs than CF through 6 months of age (Mean±SEM days: 15.9±2.0 vs 19.3±2.8, P=0.023), which held true for infants born by C-section also (15.6±4.2 vs 20.2±7.2, P=0.048).

Conclusions: In summary, this clinical study showed that a formula with 5 specific HMOs was safe, well-tolerated, supported normal age-appropriate growth, and compared to formula without HMOs, promoted softer stools and demonstrated better immune support outcomes. These clinically relevant outcomes on 5 specific HMOs corroborate previous findings and expand findings on formula with HMOs.

Funding Sources: Abbott Nutrition