Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula—A Randomized Controlled Trial

Abstract

The present study aims to evaluate the effects of an infant formula supplemented with a mixture of prebiotic short and long chain inulin-type oligosaccharides on health outcomes, safety and tolerance, as well as on fecal microbiota composition during the first year of life. In a prospective, multicenter, randomized, double-blind study, n = 160 healthy term infants under 4 months of age were randomized to receive either an infant formula enriched with 0.8 g/dL of Orafti®Synergy1 or an unsupplemented control formula until the age of 12 months. Growth, fever (>38 °C) and infections were regularly followed up by a pediatrician. Digestive symptoms, stool consistency as well as crying and sleeping patterns were recorded during one week each study month. Fecal microbiota and immunological biomarkers were determined from a subgroup of infants after 2, 6 and 12 months of life. The intention to treat (ITT) population consisted of n = 149 infants. Both formulae were well tolerated. Mean duration of infections was significantly lower in the prebiotic fed infants (p < 0.05). The prebiotic group showed higher Bifidobacterium counts at month 6 (p = 0.006), and higher proportions of Bifidobacterium in relation to total bacteria at month 2 and 6 (p = 0.042 and p = 0.013, respectively). Stools of infants receiving the prebiotic formula were softer (p < 0.05). Orafti®Synergy1 tended to beneficially impact total daily amount of crying (p = 0.0594). Supplementation with inulin-type prebiotic oligosaccharides during the first year of life beneficially modulates the infant gut microbiota towards higher Bifidobacterium levels at the first 6 months of life, and is associated with reduced duration of infections.

Infant feeding practice and gastrointestinal tolerance: a real-world, multi-country, cross-sectional observational study

“…A review of studies that evaluated stool characteristics among infants receiving a mixture of prebiotics found softer stools in the infants receiving formula with prebiotics in 4 out of 5 studies [16]. Multiple other studies have also demonstrated that infant formulas supplemented with prebiotics or mixtures of pre-and probiotics are associated with softer stools [17,[20][21][22][23]. Notably the previous studies are all randomized clinical trials; thus, it is reassuring that similar effects for stooling were observed in our real-world observational study.…”

Neonatal Programming of Microbiota Composition: A Plausible Idea That Is Not Supported by the Evidence

“…For prebiotics, significant microbiotal changes have been reported for post-supplement durations of between 2 weeks (Waligora-Dupriet et al, 2007) and 6 months (Salvini et al, 2011), with no information on further progression. Longerlasting impact appears unlikely since differences in the relative abundance of the bifidobacteria, which are characteristic of prebiotic supplementation, are only detected at 2 and 6 months in infants supplemented for 12 months (Neumer et al, 2021). For probiotics, no systematic impact on microbiota composition has been observed (e.g., Rinne et al, 2006vs.…”

Reported Prevalence and Nutritional Management of Functional Constipation among Young Children from Healthcare Professionals in Eight Countries across Asia, Europe and Latin America

“…The respondents also reported inulin and FOS as the next best fibers to manage constipation. FOS and inulin have been shown in numerous studies to soften stool and/or increase stool consistency in infants and young children [ 21 , 22 , 23 , 24 , 25 , 26 , 27 ]. Unlike in the other regions, GOS were chosen as the second-best fiber to reduce constipation symptoms in Saudi Arabia and Mexico.…”