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Bovine milk oligosaccharides in infant formula improves stooling pattern and sleeping episodes

Bovine milk oligosaccharides in infant formula improves stooling pattern and sleeping episodes

This is the first clinical trial investigating the safety and efficacy of an alpha-lactalbumin and sn-2 palmitate enriched infant formula supplemented with 7.2 g bovine milk derived oligosaccharides (MOS) per liter of reconstituted formula.

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Study design

  • Double-blind, parallel-group, randomized controlled trial of healthy, term infants in Philippines
     

Subject and Intervention

Control group (n = 112),

  • Fed an intact-protein, bovine milk-based, whey-predominant, alpha-lactalbumin-enriched term infant formula with 13.4 g/L protein and 45% high sn-2 palmitate fat blend
     

Test group (n = 114),

  • Fed a formula identical to control formula except for a total 7.2 g/L supplementation of bovine-milk derived oligosaccharides (MOS)
     

Study duration

  • Baseline (21-26 days) to 6 months of age
  • Clinic visits were conducted at enrolment, 1.5 month, 2.5 month, 4 and 6 months
  • Phone calls were conducted midway between clinical visits and 14 days after 6-month visit
     

Results

Growth,

  • Both groups followed the median of WHO growth standards for z-scores for weight-for-age, length-for-age, head circumference-for-age, and BMI-for-age throughout the 6 months
  • No significant differences were observed in any z-scores between groups at any visits
     

Stool consistency,

  • At post-enrollment timepoints, test group had significantly lower mean stool consistency (i.e. softer stools) than control (p < 0.001 for 2.5- and 4-month visits; p < 0.005 for 6-month visit);
  • Test group had significantly fewer parental reports of harder stools than control (OR = 0.32, 95% CI: 0.20, 0.49, p < 0.0001);
     

Gastrointestinal tolerance,

  • Test group had significantly reduced difficulties in passing stool than control (OR = 0.25, 95% CI: 0.09, 0.65, p = 0.005);
  • No significant differences were observed between groups in parent-reported incidences of spitting-up/vomiting, flatulence, and fussiness caused by flatulence;
  • Test group had significantly lower overall incidence of sleeping episodes (IRR = 0.95, 95% CI: 0.91-0.99, p = 0.023);
     

Parent-reported and physician-reported adverse events (AE),

  • The overall number of infants with at least one AE report was similar in both groups;
  • In these infants, 99.5% of control group and 100% of test group had AEs unrelated to study feedings;
     

Conclusion

  • MOS-supplementation in infant formula is safe and well-tolerated, supports normal infant growth and improves stooling pattern without increasing parent-reported and physician-confirmed adverse events.
     

Link to publication:

https://pubmed.ncbi.nlm.nih.gov/33958719/
 

WYE-EM-078-MAY-21

Reference

Estorninos E et al. Infant formula containing bovine milk-derived oligosaccharides supports age-appropriate growth and improves stooling pattern. Pediatric Research. 2021;doi:10.1038/s41390-021-01541-3. Online ahead of print.
 

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