[Hot Science] Randomized clinical trial on bovine milk oligosaccharides (BMOs) supplementation, intestinal biomarkers and microbiota

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Neonatology Paediatrics Gut health Nutrition & Disease Management

In this newly published randomized clinical trial (RCT), bovine milk oligosaccharides (BMOs) was the only component which differed between the test formulas, hence, potentially the main driver for the observed effects on intestinal biomarkers and microbiota of the infant subjects.

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Part I. Healthy full-term infants were enrolled at birth and randomized within the first 48 hours to receive one of the following interventions,

  • Control group (n = 40) – standard formula
  • FLP group (n = 44) – standard formula + bovine lactoferrin at 1 g/L + Bifidobacterium animalis ssp lactis CNCM I-3446 (B. lactis) at 3.7 x 104 CFU/g powder formula
  • FLPP group (n = 43) – FLP formula (same levels of lactoferrin and B. lactis) + bovine milk oligosaccharides (BMOs) at 6 g/L
  • BF group (n = 75) – breastfed infants as reference


Part II. Washout period

  • All test formula groups received a low protein starter formula with 67 kcal/100 mL energy, 1.8 g/100 kcal protein and 5.3 g/100 kcal fat
  • BF group remained breastfed

Part III. Data collection at weeks 1, 2, 4, and 8, including one or more of the below parameters:

  • Growth, digestive tolerance, adverse events
  • Gut barrier function maturation
  • Stool microbiota profile

Key Findings


  • All groups had comparable anthropometric parameters at baseline
  • No significant differences were observed between groups post-intervention
  • All growth parameters followed the WHO standard curves

Adverse events,

  • No differences in reported adverse events between groups

Digestive tolerance,

  • FLPP group showed less hard and formed stools and more soft stools as compared to control and FLP groups during intervention period
  • There were no significant differences between the different feeding groups for spitting-up and vomiting frequencies, infant’s crying time and colic frequency

Gut barrier function maturation,

  • Compared to BF group, infants fed BMOs (i.e. FLPP group) had lower calprotectin levels along the intervention peiod
  • Infants fed BMOs (i.e. FLPP group) also had elastase and α-1Antitrypsin (AAT) levels closer to breastfed infants during the intervention period, while concentrations were higher in the F and FLP groups when compared to BF group
  • No differences for neopterin between groups along the intervention period

Stool microbiota profiles,

  • Infants fed BMOs (i.e. FLPP group) showed microbiota profile overlap with breastfed group at week 1 and 4, both dominated by Bifidobacterium (at 77% for FLPP group and at 81% for breastfed infants)


  • Correlation was observed between microbiota profile changes and gut maturation marker calprotectin
  • The supplementation of BMOs seems to favor gut maturation closer to that of breastfed infants


Link to publication: https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/32443684/


Castanet M et al. Early effect of supplemented infant formulae on intestinal biomarkers and microbiota: a randomized clinical trial. Nutrients. 2020;12:1481.

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