Abstract
Tolerance development is an important clinical outcome for infants with cow's milk allergy. This multicenter, prospective, randomized, double-blind, controlled clinical study (NTR3725) evaluated tolerance development to cow's milk (CM) and safety of an amino acid-based formula (AAF) including synbiotics (AAF-S) comprising prebiotic oligosaccharides (oligofructose, inulin) and probiotic Bifidobacterium breve M-16V in infants with confirmed IgE-mediated CM allergy. Subjects aged ≤13 months with IgE-mediated CM allergy were randomized to receive AAF-S (n= 80) or AAF (n= 89) for 12 months. Stratification was based on CM skin prick test wheal size and study site. After 12 and 24 months, CM tolerance was evaluated by double-blind, placebo-controlled food challenge. Alogistic regression model used the all-subjects randomized data set. At baseline, mean± SD age was 9.36± 2.53 months. At 12 and 24 months, respectively, 49% and 62% of subjects were CM tolerant (AAF-S 45% and 64%; AAF 52% and 59%), and not differ significantly between groups. During the 12-month intervention, the number of subjects reporting at least 1 adverse event did not significantly differ between groups; however, fewer subjects required hospitalization due to serious adverse events categorized as infections in the AAF-S versus AAF group (9% vs 20%; P= .036). After 12 and 24 months, CM tolerance was not different between groups and was in line with natural outgrowth. Results suggest that during the intervention, fewer subjects receiving AAF-S required hospitalization due to infections.
Highlights
Tolerance development is an important clinical outcome for infants with cow’s milk allergy
Cesarean section Vaginal Family history of atopy At least 1 parent Medical history of presenting allergy complaints of: Eczema Acute urticaria Wheezing Dyspnea Stridor Dysphonia Aphonia Sneezing/congestion Conjunctivitis Severe abdominal symptoms Change in behavior such as irritability Sensitized to multiple foods Subjects breast-fed at all Yes No Subjects exclusively breast-fed until study entry Type of bottle feeding Whole protein Extensively hydrolyzed formula acid– based formula (AAF) Missing
The mean percentages of Eubacterium rectale/Clostridium coccoides (ER/CC) were significantly lower in the AAF formula with synbiotics (AAF-S) group than the AAF group at 6 months (14.6% vs 32.6%, P 5 .007) but not at 12 months (21.2% vs 35.7%, P 5 .058). To our knowledge, this is the first randomized controlled study to investigate the natural tolerance development determined by DBPCFC in infants with confirmed IgE-mediated CM allergy (CMA) receiving an AAF with or without synbiotics
Summary
Tolerance development is an important clinical outcome for infants with cow’s milk allergy. Objective: This multicenter, prospective, randomized, doubleblind, controlled clinical study (NTR3725) evaluated tolerance development to cow’s milk (CM) and safety of an amino acid– based formula (AAF) including synbiotics (AAF-S) comprising prebiotic oligosaccharides (oligofructose, inulin) and probiotic Bifidobacterium breve M-16V in infants with confirmed IgEmediated CM allergy. At 12 and 24 months, respectively, 49% and 62% of subjects were CM tolerant (AAF-S 45% and 64%; AAF 52% and 59%), and not differ significantly between groups. During the 12-month intervention, the number of subjects reporting at least 1 adverse event did not significantly differ between groups; fewer subjects required hospitalization due to serious adverse events categorized as infections in the AAF-S versus AAF group (9% vs 20%; P 5 .036). Results suggest that during the intervention, fewer subjects receiving AAF-S required hospitalization due to infections. (J Allergy Clin Immunol 2022;149:650-8.)
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