Nutricia welcomes the publication in the Journal of Pediatric Gastroenterology and Nutrition of a safety and tolerance study of a novel anti-regurgitation baby formula

Nutricia is pleased to announce publication in the Journal of Pediatric Gastroenterology and Nutrition (JPGN) of the results of a study comparing a baby formula indicated for the dietary management of regurgitation with an anti-regurgitation (AR) baby formula containing pre- and postbiotics1.

The study, entitled “Safety and Tolerance of a Novel Anti-Regurgitation Formula: A double-blind, randomized, controlled trial”, showed that the AR baby formula containing pre- and post-biotics was safe and well tolerated by infants with regurgitation. A post-hoc analysis of the trial data also determined that the AR baby formula containing pre- and postbiotics led to a greater improvement among those infants with the most severe gastrointestinal symptoms – such as stooling, spitting-up/vomiting, crying, fussiness and flatulence. Nutricia is supporting such research to understand and highlight how certain gastrointestinal conditions that affect infants and babies can be managed through nutritional interventions – such as AR formulas containing pre- and postbiotics.

During the design and setup of the study, only those parents who had already decided to fully formula feed were informed about the study. Parents were asked to complete the Infant Gastrointestinal Symptom Questionnaire (IGSQ) – a method whereby parents record their baby’s incidents of stooling, spitting-up/vomiting, crying, fussiness and flatulence. Completed questionnaires were converted into IGSQ scores to compare the established AR baby formula with the AR baby formula containing pre- and postbiotics.

After four weeks, the IGSQ scores for the established versus the AR baby formula containing pre- and postbiotics were equivalent, indicating that the AR baby formula with pre- and postbiotics is safe and well-tolerated. Further, a post-hoc analysis of the trial data revealed that for infants with the most severe gastrointestinal symptoms, their IGSQ scores showed the greatest improvement when using the AR baby formula containing pre- and postbiotics.

"Regurgitation is the most common infant feeding problem – affecting roughly one in three infants, and is often associated with other gastrointestinal problems like colic and constipation. According to the latest guidelines, if babies are not breastfed, formula thickened, for example, with carob bean gum should be considered as a first line therapy option to address regurgitation. This study shows that the novel formula containing not only carob bean gum as a thickening agent and postbiotics, but also a mixture of short-chain galacto-oligosaccharide (scGOS) and long-chain fructo-oligosaccharide (lcFOS) prebiotics leads to improved outcomes in infants with severe gastrointestinal symptoms."

Dr Marc Bellaiche, Pediatrician, Dept. of Gastroenterology, Hôpital Robert-Debré, Paris and first author of the study

Infants with severe gastrointestinal distress could be considered at higher risk of being prescribed medication – such as antibiotics, which can impact a baby’s microbiome.

"We’re pleased to see this study published in JPGN, as it helps raise awareness of a very common infant feeding problem parents can face. But most importantly, it highlights the relevance of nutritional advice and interventions, which can include special formulas in non-exclusively breastfed infants."

Dr MED. Thomas Ludwig, Principal scientist, Danone Nutricia Research and co-author of the study

More information on the study can be found by visiting Danone Nutricia Research.

For more information on the study

  1. Currently available under various brand names, including: Aptamil 3 Anti Regurgitation, Nutrilon 3 Anti Regurgitation and Gallia 3 Anti Regurgitation.

Gastrointestinal health: FGIDs

Regurgitation, infantile colic and functional constipation are common functional gastrointestinal disorders (FGIDs) during infancy.

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