Abstract
Background: We sought to determine whether an extensively hydrolyzed formula (EHF) supplemented with two human milk oligosaccharides (HMO) was tolerated by infants with cow’s milk protein allergy (CMPA). Methods: A whey-based EHF (Test formula) containing 2′fucosyl-lactose (2′FL) and lacto-N-neotetraose (LNnT) was assessed for clinical hypoallergenicity and safety. The Control formula was a currently marketed EHF without HMO. Children with CMPA, aged 2 months to 4 years, were assessed by double-blind, placebo-controlled food challenges (DBPCFC) to both formulas, in randomized order. If both DBPCFC were negative, subjects participated in a one-week, open food challenge (OFC) with the Test formula. Symptoms and adverse events were recorded. Hypoallergenicity was accepted if at least 90% (with 95% confidence intervals) of subjects tolerated the Test formula. Results: Of the 82 children with CMPA that were screened, 67 (intention-to-treat [ITT] cohort—mean age 24.5 ± 13.6 months; range 2–57; 45 [67.2%] male) were randomized to receive either the Test or the Control formula during the first DBPCFC. Of these, 64 children completed at least one DBPCFC (modified intention-to-treat [mITT] cohort). Three children were excluded due to protocol deviations (per protocol [PP] cohort; n = 61). There was one allergic reaction to the Test, and one to the Control formula. On the mITT analysis, 63 out of 64 (98.4%; 95% CI lower bound 92.8%), and on the PP analysis 60 out of 61 (98.4%; 95% CI lower bound 92.5%) participants tolerated the Test formula, confirming hypoallergenicity. Conclusion: The whey-based EHF supplemented with 2′FL and LNnT met the clinical hypoallergenicity criteria and can be recommended for the management of CMPA in infants and young children.
Highlights
Cow’s milk protein is a major food allergen in infants and young children [1,2]
In the ‘Test → Control’ group, 2 subjects were not able to consume enough infant formula (
We present the first hypoallergenicity trial of an human milk oligosaccharides (HMO)-supplemented extensively hydrolyzed formula (EHF) intended for the management of infants and young children with cow’s milk protein allergy (CMPA)
Summary
Cow’s milk protein is a major food allergen in infants and young children [1,2]. Major milk allergens include caseins, as well as the whey proteins beta-lactoglobulin (BLG) and alpha-lactalbumin [2].The prevalence of IgE-mediated cow’s milk protein allergy (CMPA) varies by region, with an overall incidence of challenge-proven CMPA of 0.54% of European children under 2 years of age. [3]. Cow’s milk protein is a major food allergen in infants and young children [1,2]. The prevalence of IgE-mediated cow’s milk protein allergy (CMPA) varies by region, with an overall incidence of challenge-proven CMPA of 0.54% of European children under 2 years of age. IgE-mediated CMPA in children under 2 years of age [4]. Children with CMPA, aged 2 months to 4 years, were assessed by double-blind, placebo-controlled food challenges (DBPCFC) to both formulas, in randomized order. If both DBPCFC were negative, subjects participated in a one-week, open food challenge (OFC) with the Test formula.
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