ABSTRACT
Purpose@#Infant regurgitation is associated with other functional gastrointestinal disorders and signs and symptoms that have a major impact on the quality of life of infants and their families. This study evaluated the safety, tolerance, and real-world effectiveness of an antiregurgitation formula containing locust bean gum (LBG), prebiotics, and postbiotics to alleviate digestive symptoms beyond regurgitation. @*Methods@#This 3-month study involved infants with regurgitation requiring the prescription of an anti-regurgitation formula according to usual clinical practice. Outcomes included evaluation of the evolution of stool consistency and frequency; occurrence of colic, constipation, and diarrhea; and assessment of regurgitation severity. Infant crying, parental assessment of infant well-being, and parental satisfaction with the stool consistency were also evaluated. @*Results@#In total, 190 infants (average age: 1.9±1.1 months) were included. After three months, stool frequency and consistency remained within the normal physiological range, with 82.7% of infants passing one or two stools per day and 90.4% passing loose or formed stools. There was no significant increase in the number of infants with diarrhea, whereas a decrease was observed in the number of infants with constipation after 1 month (p=0.001) and with colic after both 1 and 3 months (p<0.001). Regurgitation severity and crying decreased and parental satisfaction with stool consistency, formula acceptability, infant well-being, and sleep quality increased. Monitoring of adverse events did not reveal any safety concerns. @*Conclusion@#Formulas containing LBG, prebiotics, and postbiotics were well tolerated and provided an effective strategy for managing infant regurgitation and gastrointestinal discomfort.
ABSTRACT
Purpose@#Thickened infant formulas reduce regurgitation frequency and volume. Because the digestive tolerance of locust bean gum-containing formulas is controversial, the effectiveness and tolerance of a locust bean gum-thickened formula in infants presenting with regurgitation was evaluated. No other interventions were allowed during the 1 month follow-up period. @*Methods@#We conducted an open, prospective, observational study of a locust bean gumthickened formula administered to infants presenting with moderate to severe regurgitation according to parents during 1 month. Effectiveness and tolerance were assessed by evaluating gastrointestinal symptoms and quality of life indicators. @*Results@#A total of 2,604 infants with an average age of 9.3±4.3 weeks were included in this 1 month trial. Regurgitation frequency and estimated volume decreased significantly (p<0.001) and the episodes were resolved completely in 48% of the infants. A significant decrease in duration of crying and episodes of gas (p<0.001), with improvement in quality of life parameters, was observed. Stool frequency increased and stool consistency softened (p<0.001) to levels within the physiologic range, consistent with the increased fiber load (0.42 g/100 mL). @*Conclusion@#Locust bean gum-thickened formula decreased infant regurgitation, was well tolerated, and improved parental quality of life. Stool composition and frequency of the infants remained within the physiologic range.