Abstract
This randomized clinical trial (Registration: NCT03085134) assessed if an extensively hydrolyzed formula (EHF) supplemented with two human milk oligosaccharides (HMO) and reduced protein content (2.20 g/100 kcal) supports normal growth in infants with cow’s milk protein allergy (CMPA). Secondary outcomes were gastrointestinal tolerability, safety, and effect on infections. Nonbreastfed infants aged 0–6 months with CMPA were enrolled. Body weight, length, and head circumference were measured monthly for 4 months (primary study endpoint), after 6 months, and at the age of 12 months. Of 200 infants screened, 194 (mean age 3.2 months) were randomized. At the 4-month follow-up, daily weight gain for the test formula was noninferior to the control formula; p < 0.005. There were no significant group differences in anthropometric parameters. Both formulas were safe and well tolerated. Infants in the HMO group had a statistically significant reduction in the frequency of upper respiratory tract infections and a lower incidence of ear infections at 12 months (per protocol analysis). The relative risk of lower respiratory tract and gastrointestinal infections was reduced by 30–40%, but this was not statistically significant due to sample size limitations. In summary, the HMO-supplemented formula supports normal growth in infants with CMPA and suggests a protective effect against respiratory and ear infections in the first year of life.
Highlights
Human milk oligosaccharides (HMO) are complex, nondigestible carbohydrates that make up the third biggest component of human milk solids [1]
The primary objective of this study was to assess if infants with cow’s milk protein allergy (CMPA) aged 0–6 months who were fed with the test formula achieved similar growth, compared to that of infants receiving the control formula
At V4, 73 infants assigned to the test and 64 assigned to control formula completed the protocol without major deviations (PP cohort)
Summary
Human milk oligosaccharides (HMO) are complex, nondigestible carbohydrates that make up the third biggest component of human milk solids [1]. HMO provide the hostspecific substrate for the developing gut microbiome in early infancy, with targeted enhancement of bifidobacteria [2,3]. About 1–2% of HMO are absorbed and have systemic effects on immune function and even cognitive development [4,5,6,7]. HMO reduce infections in infancy by interfering with the mucosal attachment of respiratory or enteric pathogens. HMO reduce the risk of infection with a range of viral pathogens, including influenza virus, respiratory syncytial virus, coronaviruses, rotavirus, and norovirus [10,11,12,13]. There is in-vitro evidence that HMO reduce the mucosal adhesion of bacterial pathogens, including Streptococcus pneumoniae and Haemophilus influenzae [14]
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