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

Method

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

Growth

• 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)
   

Conclusion

• 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/