Safety and Tolerance of a Novel Anti‐Regurgitation Formula

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.

An Observational Real-Life Study with a New Infant Formula in Infants with Functional Gastro-Intestinal Disorders

“…The gastric emptying of a pHF-W is comparable to that of mother's milk and significantly faster than that of intact milk protein [56] L. reuteri was shown to reduce regurgitation and to enhance gastric emptying [57]. Different studies showed a significant effect on regurgitation within one week of dietary treatment [58][59][60].…”

Efficacy and safety of medical and nutritional management of gastroesophageal reflux in formula-fed infants: a narrative review

“…This percentage was the same as before the intervention started [30]. The recent trial comparing LBG thickened formula with and without FOS and GOS (and postbiotics) showed no difference in efficacy [11 ▪▪ ].…”

“…The efficacy of the standard and new antiregurgitation formula, both thickened with LBG was in the overall group comparable within the first week of intervention [11 ▪▪ ]. Post-hoc analyses suggest that the novel formula may result in more improvement of the gastrointestinal symptom burden in infants with more severe symptoms [11 ▪▪ ].…”

“…A multicenter RCT [11 ▪▪ ] published in 2021 refuted that LBG increased the prevalence of diarrhea stating that defecation in children fed with LBG-thickened formula resembled the stool pattern of healthy term born infants [11 ▪▪ ].…”

Infant Formulas With Postbiotics

“…Figure 1 is a flow diagram of the identification of eligible trials. In addition to 5 randomized controlled trials (RCTs) identified earlier in our 2015 systematic review (5–9), 6 new RCTs were identified (10–15) (Table 1). Characteristics of the excluded studies are summarized in Table 3, Supplementary Digital Content, http://links.lww.com/MPG/C753 .…”