Digestive Tolerance and Safety of an Anti-Regurgitation Formula Containing Locust Bean Gum, Prebiotics and Postbiotics: A Real-World Study

Marc Bellaiche; Patrick Tounian; Raish Oozeer; Emilie Rocher; Yvan Vandenplas

doi:10.5223/pghn.2023.26.5.249

Digestive Tolerance and Safety of an Anti-Regurgitation Formula Containing Locust Bean Gum, Prebiotics and Postbiotics: A Real-World Study

Pediatr Gastroenterol Hepatol Nutr. 2023 Sep;26(5):249-265. doi: 10.5223/pghn.2023.26.5.249. Epub 2023 Sep 1.

Authors

Marc Bellaiche¹, Patrick Tounian², Raish Oozeer³, Emilie Rocher³, Yvan Vandenplas⁴

Affiliations

¹ Department of Gastroenterology and Pediatric Nutrition, Hospital Robert-Debré, AP-HP, Paris, France.
² Department of Pediatric Nutrition and Gastroenterology, Trousseau Hospital, AP-HP, Sorbonne Université, Paris, France.
³ Danone Nutricia Research, Utrecht, Netherlands.
⁴ KidZ Health Castle, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.

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 anti-regurgitation 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.

Keywords: Colic; Constipation; Crying; Defecation; Diarrhea; Digestive tolerance; Gastroesophageal reflux; Infant formula; Infant health; Infant well-being; Locust bean gum; Nutritional support; Quality of life.