Effects of Infant Formula With Human Milk Oligosaccharides on Growth and Morbidity: A Randomized Multicenter Trial.

Fighting Infections with HMOs: Results from a Randomized Control Trial

Highlights ¹

This clinical summary explains that human milk oligosaccharides (HMOs) reduce the occurrence of infant morbidities such as bronchitis and lower respiratory tract infections (LRTIs) and also reduces medication usage such as antibiotics and antipyretics.

Background

HMOs have varied structures, types, and concentrations in human milk.¹ 2′-fucosyllactose (2’-FL) is one of the most abundant HMO, with a concentration of 10-15 g/L in mature milk.^1,2 HMOs are crucial in promoting and maintaining the growth of gut flora and strengthening the immune system.¹ 2’-FL is also known to support the growth of certain microbiome species.¹

Objective¹

To assess the role of HMO such as 2’-FL in reducing the incidence of bronchitis, LRTIs, and lesser use of antibiotics and antipyretic medications.

Results¹

1.Bronchitis

• Infants had significantly fewer reports of bronchitis at 4, 6, and 12 months with test feed.
• Statistically significant difference was observed through 12 months in an infants’ subgroup born via c-section for bronchitis (test vs control; 3.1% vs. 34.4%).

2.Lower respiratory tract infections

• Statistically significant differences for LRTIs was observed in an infants’ subgroup born via cesarean section (test vs. control: at 6 months (6.3 % vs 28.1%) and at 12 months (12.5% vs 40.6%).
• Fewer parent-reported adverse event clusters with test feed through 12 months.

3.Antipyretic use

• Reports of antipyretic usage was fewer through the first 4 months with test feed

4.Antibiotic use

• Antibiotics usage was significantly lower through 6 and 12 months with test feed.

5.Parent-reported adverse events (AEs)

• At least 1 parent-reported AE with a similar overall percentage in both groups: (test vs control: 84.1% vs 90.8%)
• This was observed in the first 4 months with exclusive infant feeds

• At least 1 serious parent-reported AE in both groups at 4 months (6 infants (6.8%) in test group, 10 infants (11.5%) in control group)

Figure 2 demonstrates the combined reported events in tabular and graphical form.

† Refers to parent-reported morbidity or medication use; AE: Adverse event; CI: Confidence interval; LRTI: Lower respiratory tract infection; OR: Odds ratio

Figure 2 Comparison of parent-reported adverse events and medication use in the test vs. control group (Adapted from Puccio G et al., 2017)¹

Conclusion

HMOs are a vital component of human milk, contributing to the overall well-being of infants. This randomized trial showed that infant feeds with HMO (2’-FL) are safe and well-tolerated in infants. HMOs help in improving immunity and fighting infections. Infants fed on feeds with HMO such as 2’-FL show lesser incidence of infections such as bronchitis and LRTIs. These infants also need fewer antipyretics and antibiotics to combat morbidities.