4. Discussion
allergic, allergy-associated diseases, IgE-mediated CMPA, CMPA, Atopic Dermatitis, allergy, atopic dermatitis, mixed-fed, allergic disease, AD, allergy-associated disease
ALLERGY, ATOPIC DERMATITIS, ATOPIC DERMATITIS
The present study indicates that infants at high risk for allergy (based on a family history of allergy) may benefit from a combination of breastmilk and the studied infant formula with partially hydrolyzed whey protein. This combination resulted in a lower incidence of AD in a subpopulation of infants with a positive family history for AD, in both ITT and PP populations. A trend was found towards a lower incidence of CMPA, including food challenge confirmed cases, in the pHF group, as compared to EBF, in both the ITT and PP data sets. The incidences of AD and CMPA were similar between the EBF and SF groups. With respect to growth, all groups showed small, negative mean Z-scores for body weight and BMI at baseline. Throughout the study growth in all groups complied with WHO standards, with the SF group showing the highest increase in body weight and BMI, while length increased the most in the pHF group. Z-scores for weight in the EBF and pHF groups were close together and developed similarly throughout the study, with an initial decrease at the age of 4 months in the EBF group and an increase thereafter.The protective effect on certain allergy outcomes in the pHF group was mainly observed in the mixed-fed infants, which represent the vast majority of the pHF group in our cohort. The number of exclusively formula-fed infants was too small to draw any conclusion. In line with our results, the GINI study also showed the protective effect of a partially hydrolyzed formula on allergic manifestations, i.e., atopic dermatitis [Studies on the role of early supplementation of intact CMP on the later development of allergy-associated diseases are indicative of a protective effect, depending however on the timing of CMP formula introduction. Early CMP introduction, but not earlier than two weeks of life, has been associated with a lower risk for IgE-mediated CMPA [The lower incidence of AD in the pHF group was noted in infants with a positive family history of AD. Atopic Dermatitis in the core family has been long considered a significant risk factor for the development of any allergy-associated disease in the offspring, compared to any other allergic disease, as shown by epidemiological, intervention, and genetic studies [With respect to growth outcomes, although increases in body weight and BMI mean Z-scores from baseline to 4 and 6 months were more pronounced for the SF group, respective length increases were significantly higher in the pHF group. It has been previously documented that the specific whey-based pHF formula used in our study, is non-inferior regarding all infant growth outcomes compared to SF, although a margin of −3 g/day was noted in a three-month intervention period for the pHF compared to the SF group [