(P07-068-23) Parent-Reported Improved Gastrointestinal Tolerance and Parental Perspectives in Infants Identified as Fussy and Fed Infant Formula With 5 Human Milk Oligosaccharides

Objectives: Infant formula switching is common in early infancy with symptoms of formula intolerance as the main cause. Human milk oligosaccharides (HMOs) were one of the first substances to be recognized as influencing gastrointestinal (GI) health. In particular, formulas with 5 HMOs have demonstrated GI tolerance in healthy, term infants, similar to breastfed infants, helping to narrow the gap between formula and human milk. This prospective, multi-center, single-arm study (NCT04915937) assessed symptoms of formula intolerance before and after switching to a formula with 5 HMOs (2′-FL, 3-FL, LNT, 3′-SL, and 6′-SL: Similac, Abbott Nutrition).

Methods: Healthy, term, formula-fed infants identified as “very fussy” or “extremely fussy” by parents were enrolled between 7-65 days of age. Study visits occurred at enrollment, day 7, and day 28. The primary variable was change in fussiness severity after 1 day on formula with 5 HMOs. Other variables were change in hours of crying, number of spit-ups associated within 1 hour of feeding, amount of gassiness, parental perspectives, formula satisfaction, anthropometrics, and adverse events. Statistical analyses were performed using paired t-tests or signed rank tests (SAS Version^® 9.4) at α=0.05.

Results: This study enrolled 45 infants from 10 US sites in 2021-2022. The mean ± SEM age of infants was 29.8 ± 2.4 days. Formula intake was ad libitum with a mean of 712 ± 23 mL/day. Weight and length were normal. The primary outcome was achieved. After 28 days of feeding their infants formula with 5 HMOs, parents reported their infants had a median reduction of 50% in hours of crying, 67% in number of spit-ups, 33% in amount of gassiness, and 60% in severity of fussiness (P≤0.05). The % of parents reporting good quality of life, satisfaction with sleep, low stress levels, and satisfaction with the formula were 97%, 80%, 53%, and 93%, respectively.

Conclusions: This study investigated for the first time parents perspectives on formula with 5 HMOs in fussy infants. Overall, parents reported their fussy infants fed formula with 5 HMOs had improvements in GI tolerance, including infant crying time, number of spit-ups, amount of gassiness, and severity of fussiness after 28 days feeding formula with 5 HMOs. Formula with 5 HMOs supported normal growth and safe use in infants for 28 days.

Funding Sources: Abbott Nutrition