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.