Acceptability of "High sn-2" Infant Formula in Non-Breast Fed Healthy Term Infants Regarding Gastrointestinal Tolerability by Both Parents and Pediatrician: An Open-Label Pilot Study in the Gulf Cooperation Council (GCC) Countries.

Abstract

Recent studies have highlighted the positive impact of high sn-2 formulas on gastrointestinal (GI) tolerance. We assessed the GI tolerance, acceptability, and safety of high sn-2 infant formula among non-breastfed healthy term infants in the Gulf countries. A multicenter observational study was conducted on 227 healthy-term infants who were prescribed high sn-2 palmitate infant formula and received a minimum of two formula feedings per day for the past two weeks prior to the study’s initiation. The number of stools per day decreased significantly from a median of four (interquartile range [IQR] = 4) at baseline to 3.0 (2) stools per day at the end of follow-up (p = 0.015). The percentage of stool amount changed significantly, where 61.2% and 33.7% of the infants had an amount of 25–50% of the diaper and >50% of the diaper, respectively (p < 0.001) at the end of the follow-up. Similarly, the percentage of hard stool decreased significantly from 17.4% at baseline to 0.4% of the population at week 12 (p < 0.00). The prevalence of colic and abdominal distention declined from 21.4% and 39.9% at baseline to 2.9% and 9.4% at week 12, respectively (p < 0.05). The same decline was observed in abdominal distension and regurgitation score (p < 0.05).