Safety and Tolerance of a Novel Anti-Regurgitation Formula: A Double-Blind, Randomized, Controlled Trial

Marc Bellaiche, Thomas Ludwig, Małgorzata Arciszewska, Anke Bongers, Cédrico Gomes, Agnieszka Świat, Faouzi Dakhlia, Anne Piollet, Raish Oozeer, Yvan Vandenplas, Marc Bellaiche, Thomas Ludwig, Małgorzata Arciszewska, Anke Bongers, Cédrico Gomes, Agnieszka Świat, Faouzi Dakhlia, Anne Piollet, Raish Oozeer, Yvan Vandenplas

Abstract

Objectives: A novel anti-regurgitation (AR) formula has been designed to support gut health and improve gastrointestinal (GI) symptoms beyond regurgitation. This study assessed the tolerance and safety of this new AR formula.

Methods: This was a 4-week double-blind, randomized, controlled trial with a 4-week extension in formula-fed infants with regurgitation. The new AR (Test) formula contained 0.4 g/100 mL locust bean gum (LBG) as thickener, partly fermented formula with postbiotics, and short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS) (0.4 g/100 mL, ratio 9:1). The Control AR formula contained LBG (0.4 g/100 mL) with postbiotics and has a history of safe use. The primary outcome was the Infant Gastrointestinal Symptom Questionnaire (IGSQ) sum score including stooling, spitting-up/vomiting, crying, fussiness and flatulence.

Results: All 182 infants screened were enrolled in the study. The primary analysis showed the equivalence of the IGSQ sum scores at Week 4 between groups. IGSQ sum scores improved significantly within 1 week (Mixed Model Repeated Measurement [MMRM], P < 0.001). Post-hoc analyses showed a bigger improvement of the IGSQ score in the Test (n = 38) versus Control (n = 44) group (MMRM, P = 0.008) in infants with more severe gastrointestinal (GI) symptoms (IGSQ score ≥35). Stool characteristics were comparable between groups. Growth related z scores were in line with the WHO child growth standards and both groups showed improvement of regurgitation. Adverse events did not show any safety concerns.

Conclusions: The novel AR formula combining LBG, scGOS/lcFOS and postbiotics is well-tolerated, safe and supports adequate growth during the intervention. Post-hoc analyses suggest that the formula results in more improvement of GI symptom burden in infants with more severe symptoms.

Conflict of interest statement

Conflicts of Interest: T.L., A.B. and R.O. are employees of Danone Nutricia Research (Utrecht, The Netherlands). None of the other authors have a conflict of interest.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

Figures

FIGURE 1
FIGURE 1
Flow diagram of participants through study, from enrolment to study completion.
FIGURE 2
FIGURE 2
Distribution of Infant Gastrointestinal Symptom Questionnaire (IGSQ) sum scores from baseline to Week 4 in the per-protocol population. The bottom and top edges of the box are located at the sample 25th and 75th percentiles. The median is represented by the horizontal line. The whiskers of the box plots show the minimum and maximum values.
FIGURE 3
FIGURE 3
Percentage of subjects with specific stool consistency category based on parent reported diary in the all-subjects-treated population.
FIGURE 4
FIGURE 4
Distribution of Infant Gastrointestinal Symptom Questionnaire (IGSQ) sum scores for subpopulations with (A) baseline IGSQ sum scores ≥35 and with (B) baseline IGSQ sum scores

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Source: PubMed

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