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

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...

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Veröffentlicht in:Pediatric gastroenterology, hepatology & nutrition hepatology & nutrition, 2023, Vol.26 (5), p.249-265
Hauptverfasser: Marc Bellaiche, Patrick Tounian, Raish Oozeer, Emilie Rocher, Yvan Vandenplas
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container_issue 5
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container_title Pediatric gastroenterology, hepatology & nutrition
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creator Marc Bellaiche
Patrick Tounian
Raish Oozeer
Emilie Rocher
Yvan Vandenplas
description 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
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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&lt;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. 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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&lt;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. 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source KoreaMed Synapse; KoreaMed Open Access; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; PubMed Central Open Access
title Digestive Tolerance and Safety of an Anti-Regurgitation Formula Containing Locust Bean Gum, Prebiotics and Postbiotics: A Real-World Study
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