Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial

Abstract

This study evaluated the effect of a partly fermented infant formula (using the bacterial strains Bifidobacterium breve C50 and Streptococcus thermophilus 065) with a specific prebiotic mixture (short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS; 9:1)) on the incidence of gastrointestinal symptoms, stool characteristics, sleeping and crying behaviour, growth adequacy and safety. Two-hundred infants ≤28 days of age were assigned either to experimental infant formula containing 30% fermented formula and 0.8 g/100 mL scGOS/lcFOS or to non-fermented control infant formula without scGOS/lcFOS. A group of breastfed infants served as a reference. No relevant differences in parent-reported gastrointestinal symptoms were observed. Stool consistency was softer in the experimental versus control group with values closer to the breastfed reference group. Daily weight gain was equivalent for both formula groups (0.5 SD margins) with growth outcomes close to breastfed infants. No clinically relevant differences in adverse events were observed, apart from a lower investigator-reported prevalence of infantile colic in the experimental versus control group (1.1% vs. 8.7%; p < 0.02). Both study formulae are well-tolerated, support an adequate infant growth and are safe for use in healthy term infants. Compared to the control formula, the partly fermented formula with prebiotics induces stool consistencies closer to breastfed infants.

A Partly Fermented Infant Formula with Postbiotics Including 3′-GL, Specific Oligosaccharides, 2′-FL, and Milk Fat Supports Adequate Growth, Is Safe and Well-Tolerated in Healthy Term Infants: A Double-Blind, Randomised, Controlled, Multi-Country Trial

“…The analysis of the primary objective was achieved by demonstrating the equivalence in daily weight gain from baseline to 17 weeks of age in infants receiving the Test compared to the Control IF. In addition, the mean (SE) values of daily weight gain 31.00 (0.59) g/day and 31.08 (0.60) g/day in the Test and Control group in the current study are in line with previously published data from other studies evaluating IF [24,25,31]. We have previously reported a mean (SD) daily weight gain of 28.3 (7.4) g/day and 30.1 (6.6) g/day for infants fed a partly fermented formula with scGOS and lcFOS or a non-fermented IF without scGOS and lcFOS until 17 weeks of age [24].…”

Infant Formula Supplemented with Biotics: Current Knowledge and Future Perspectives

“…Other technologies are available but, currently, only used for analytical and research purposes. While 2′-FL and LNnT are obtained by chemical synthesis, 3′-GL occurs as a bacterial by-product during milk fermentation [ 12 , 13 ]. Besides these three examples, further HMOs are in the pipeline for application in infant formula [ 81 ].…”

“…Recently, a specific fermentation process has been developed for infant nutrition, using two specific types of food-grade lactic acid producing microorganisms ( Bifidobacterium breve C50 and Streptococcus thermophilus 065) and naturally delivering postbiotics [ 12 , 124 , 125 ].…”

“…Two human milk oligosaccharides (HMOs), 2′-fucosyllactose (2′FL) and lacto-N-neotetraose (LNnT), are recent examples of optional ingredients being added to infant formula [ 8 , 9 , 10 , 11 ]. However, little attention has yet been given to 3′-galactosyllactose (3′-GL), which is an HMO present in human milk that may also naturally occur in fermented infant formula derived by milk fermentation [ 12 , 13 ]. This narrative review will focus on these most recent developments in infant formula as examples of ‘biotics’ aiming to resemble human milk functions in infant formula.…”

The Newest Infant Nutrition Concepts: Postbiotics and Long-Chain Polyunsaturated Fatty Acids

“…У іншому дослідженні Alfonso Rodriguez-Herrera і співавт. [38] вивчали вплив ферментованої суміші на консистенцію випорожнень у дітей. У дослідженні взяли участь 200 немовлят, які були розподілені на 2 групи.…”