Confirmed Hypoallergenicity of a Novel Whey-Based Extensively Hydrolyzed Infant Formula Containing Two Human Milk Oligosaccharides

• Published in: Nutrients Vol. 11; no. 7; p. 1447
• Main Authors: Nowak-Wegrzyn, Anna, Czerkies, Laura, Reyes, Kemuel, Collins, Barbara, Heine, Ralf G.
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 26.06.2019; MDPI
• Subjects: Age; Babies; Baby foods; breast milk; Breastfeeding & lactation; Carbohydrates; Child, Preschool; children; confidence interval; Cross-Over Studies; Double-Blind Method; Drug dosages; Female; Food allergies; Humans; hydrolysis; hypersensitivity; Infant; Infant Formula - adverse effects; infant formulas; infants; Lactose; Male; males; Microbiota; Milk; Milk Hypersensitivity - diagnosis; Milk Hypersensitivity - immunology; Milk Hypersensitivity - therapy; milk proteins; Nutrition; Nutritive Value; oligosaccharides; Oligosaccharides - administration & dosage; Oligosaccharides - adverse effects; Oligosaccharides - immunology; Protein Hydrolysates - administration & dosage; Protein Hydrolysates - adverse effects; Protein Hydrolysates - immunology; Proteins; Time Factors; Treatment Outcome; Trisaccharides - administration & dosage; Trisaccharides - adverse effects; Trisaccharides - immunology; Whey Proteins - administration & dosage; Whey Proteins - adverse effects; Whey Proteins - immunology; New York; United States > US; Switzerland; human milk oligosaccharides; whey; cow’s milk protein allergy; infant formula; food allergy; oral food challenge
• ISSN: 2072-6643; 2072-6643
• DOI: 10.3390/nu11071447

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.