Growth and safety evaluation of infant formulae containing oligosaccharides derived from bovine milk: a randomized, double-blind, noninferiority trial

Meli, Ferdinando; Puccio, Giuseppe; Cajozzo, Cinzia; Ricottone, Giovanni Licata; Pecquet, Sophie; Sprenger, Norbert; Steenhout, Philippe

doi:10.1186/s12887-014-0306-3

Cited by 58 publications

(61 citation statements)

References 24 publications

(29 reference statements)

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“…It is also of interest that Staphylococcus counts were lowered in the Test group. These findings are similar to those recently reported, where infants fed formula containing BMOS, B. longum and Lactobacillus rhamnosus or BMOS and B. lactis were shown to have higher bifidobacteria and lactobacilli counts and lower clostridia counts compared with a Control formula (10,16).…”

Section: Discussionsupporting

confidence: 81%

Starter formula enriched in prebiotics and probiotics ensures normal growth of infants and promotes gut health: a randomized clinical trial

Radkë¹,

Picaud²,

Loui³

et al. 2016

Pediatr Res

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Articles Clinical Investigation nature publishing groupBackground: Prebiotics and probiotics exert beneficial effects by modulating gut microbiota and immune system. This study evaluates efficacy and safety of an infant formula containing bovine milk-derived oligosaccharides and Bifidobacterium animalis ssp lactis (B. lactis) (CNCM I-3446) on incidence of diarrhea and febrile infections during the first year of life (primary outcome). Methods: Full-term infants receiving Test or Control (without bovine milk-derived oligosaccharide and B. lactis) formulae were enrolled in a multicenter, randomized, controlled, and double-blind trial with a reference breastfeeding group. . results: 413 infants were assigned between Test (n = 206) and Control (n = 207) formula. There was no significant difference for diarrhea and febrile infections incidence between groups at 6 (odds ratio (95% confidence interval) = 0.56 (0.26-1.15), P = 0.096) and 12 mo (odds ratio = 0.66 (0.38-1.14), P = 0.119). Test formula was well tolerated, anthropometrics parameters were not significantly different between groups and aligned with WHO growth standards up to 12 mo. Data from test group showed that gut microbiota pattern, fecal IgA and stool pH were brought to be closer to those of breastfed infants. conclusion: An infant formula enriched with bovine milkderived oligosaccharide and B. lactis supports normal infant growth, is well tolerated and improves intestinal health markers. No differences in diarrhea and febrile infection incidence were found in the population studied.

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Section: Discussionsupporting

confidence: 81%

Starter formula enriched in prebiotics and probiotics ensures normal growth of infants and promotes gut health: a randomized clinical trial

Radkë¹,

Picaud²,

Loui³

et al. 2016

Pediatr Res

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“…The absence of any genotoxicity or subchronic toxicity associated with 3′‐SL is to be expected, as it is endogenous in human and mammalian milks (Thurl, Munzert, Boehm, Matthews, & Stahl, ; Urashima, Saito, Nakamura, & Messer, ) and no undesirable impurities are introduced during the manufacturing process. It has also been demonstrated in clinical studies that biosynthesized 3′‐SL is well tolerated in humans at up to 20 g/day (Meli et al, ; Parente, Cucino, Anderloni, Grandinetti, & Bianchi Porro, ; Rasko, Wang, Monteiro, Palcic, & Taylor, ). Moreover, acute toxicity of 3′‐SL is negligible, with a median lethal dose (LD 50 ) value of >20 g/kg it is has the lowest toxicity rating and is considered ‘relatively harmless’ (Altug, ).…”

Section: Discussionmentioning

confidence: 99%

Toxicological safety assessment of the human‐identical milk oligosaccharide 3′‐sialyllactose sodium salt

Phipps

Baldwin

Lynch

et al. 2019

J of Applied Toxicology

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Human breastmilk is a mixture of nutrients, hormones and bioactive molecules that are vital for infant growth and development. Infant formula (IF) lacks many of these compounds, most notably human milk oligosaccharides (HMOs), which are abundant in breastmilk but scarce in IF. Sialyllactoses, such as 3′‐sialyllactose, constitute a large portion of the HMO fraction. To produce IF that matches breastmilk more closely, biosynthesized human‐identical milk oligosaccharides (structurally identical to HMOs) such as 3′‐sialyllactose sodium salt (3′‐SL) are proposed for use in IF and foods for the general population. The safety assessment of 3′‐SL comprised in vitro genotoxicity tests and a 90‐day oral (gavage) toxicity study. This is the first 90‐day study conducted with 3′‐SL using neonatal rats (7 days old at the start of dosing—equivalent age to newborn human infants in terms of central nervous system and reproductive development), demonstrating the safety of 3′‐SL for consumption by infants, the most sensitive age group. The neonatal rats received 3′‐SL at doses up to 5,000 mg/kg body weight (BW)/day and reference controls received 5,000 mg/kg BW/day of fructooligosaccharide (an ingredient approved for use in IF) for comparison with the high‐dose 3′‐SL group, followed by a 4‐week recovery period. There was no evidence of genotoxicity in vitro. In the absence of any test item‐related adverse effects in the 90‐day study, the high dose (5,000 mg/kg BW/day) was established as the no‐observed‐adverse‐effect level. This confirms the safety of 3′‐SL for use in IF for infants, as well as in functional foods for the general population.

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“…Membrane filtration can be used to recover oligosaccharides present in whey permeate (Cohen et al 2017, de Moura Bell et al 2016), making these compounds more readily available as a functional food ingredient. Such oligosaccharides recovered from dairy streams could serve as ingredients for infant formula, as their composition is similar to that of HMOs and such an ensemble cannot currently be produced synthetically (Meli et al 2014, Simeoni et al 2016). …”

Section: Bovine Milk Oligosaccharides: Structures and Compositionmentioning

confidence: 99%

Milk Glycans and Their Interaction with the Infant-Gut Microbiota

Kirmiz

Robinson

Shah

et al. 2018

Annu. Rev. Food Sci. Technol.

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Human milk is a unique and complex fluid that provides infant nutrition and delivers an array of bioactive molecules that serve various functions. Glycans, abundant in milk, can be found as free oligosaccharides or as glycoconjugates. Milk glycans are increasingly linked to beneficial outcomes in neonates through protection from pathogens and modulation of the immune system. Indeed, these glycans influence the development of the infant and the infant-gut microbiota. Bifidobacterium species commonly are enriched in breastfed infants and are among a limited group of bacteria that readily consume human milk oligosaccharides (HMOs) and milk glycoconjugates. Given the importance of bifidobacteria in infant health, numerous studies have examined the molecular mechanisms they employ to consume HMOs and milk glycans, thus providing insight into this unique enrichment and shedding light on a range of translational opportunities to benefit at-risk infants.

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Growth and safety evaluation of infant formulae containing oligosaccharides derived from bovine milk: a randomized, double-blind, noninferiority trial

Cited by 58 publications

References 24 publications

Starter formula enriched in prebiotics and probiotics ensures normal growth of infants and promotes gut health: a randomized clinical trial

Starter formula enriched in prebiotics and probiotics ensures normal growth of infants and promotes gut health: a randomized clinical trial

Toxicological safety assessment of the human‐identical milk oligosaccharide 3′‐sialyllactose sodium salt

Milk Glycans and Their Interaction with the Infant-Gut Microbiota

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