A novel anti-regurgitation (AR) formula comprised of locust bean gum, short-chain galacto-oligosaccharides, long-chain fructo-oligosaccharides, and postbiotics is safe and well-tolerated, according to a trial published in the Journal of Pediatric Gastroenterology and Nutrition.
The randomized, double-blind, controlled trial included 182 formula-fed infants who had at least 2 episodes of regurgitation daily for at least 7 days. Participants were randomly assigned 1:1 to receive the novel AR formula or a control AR formula already on the market for 4 weeks, with an optional 4-week extension phase (ClinicalTrials.gov Identifier: NCT03371615).
The sum score of the Infant Gastrointestinal Symptom Questionnaire (IGSQ) was the primary outcome. The questionnaire has a possible score of 13 to 65, with scores over 35 indicating severe gastrointestinal symptoms. Secondary outcomes included the scores of individual IGSQ components. Investigators also assessed adverse events and growth.
Of the 182 infants included in the study, the mean participant age was 44 days. Mean length of regurgitation prior to randomization was 29 days.
IGSQ scores improved across both groups when compared with respective baseline scores. For infants with a baseline IGSQ of 35 or greater, the novel formula was statistically superior compared with the control formula (P =.008). Adverse events were marginally higher in the control group, though the test group had more adverse skin disorders. Adequate infant growth was comparable between the 2 groups.
Study limitations include a lack of analysis on improvement of functional gastrointestinal disorder symptoms as participant age increases. Additionally, study protocol adhered to adapted Rome IV criteria for the diagnosis of regurgitation in these patients, whereas traditional criteria differs slightly.
While this preliminary study was only designed to note safety and tolerability, the benefit of the novel AR formula in participants with higher overall gastrointestinal symptoms is promising for future studies.
Disclosure: The authors declared affiliations with biotech, pharmaceutical, and/or device companies. Pleases see the original reference for a full list of author disclosures.
Bellaiche M, Ludwig T, Arciszewska M, et al. Safety and tolerance of a novel anti-regurgitation formula: a double-blind, randomized, controlled trial. JPGN 2021;73(5): 579–585. doi: 10.1097/MPG.0000000000003289