Plain language summary
Food allergies in children are becoming increasingly more common, and make a child more at risk of developing other conditions including asthma, eczema and respiratory allergies. The aim of this study was to investigate whether an extensively hydrolysed casein formula (EHCF) containing Lactobacillus rhamnosus (LGG) had an impact on risk of developing additional allergies in children with an allergy to cow's milk (IgE). It was a randomised controlled trial including 220 children aged 1-12 months in Italy who were randomly assigned to one of two groups. Group one consumed EHCF and group two consumed EHCF + LGG. The authors concluded that the addition of LGG reduced the incidence of additionally allergies in these children.
Abstract
BACKGROUND Children with cow's milk allergy (CMA) have an increased risk of other allergic manifestations (AMs). OBJECTIVE We performed a parallel-arm randomized controlled trial to test whether administration of an extensively hydrolyzed casein formula (EHCF) containing the probiotic Lactobacillus rhamnosus GG (LGG) can reduce the occurrence of other AMs in children with CMA. METHODS Children with IgE-mediated CMA were randomly allocated to the EHCF or EHCF+LGG groups and followed for 36 months. The main outcome was occurrence of at least 1 AM (eczema, urticaria, asthma, and rhinoconjunctivitis). The secondary outcome was tolerance acquisition, which was defined as the negativization of a double-blind food challenge results at 12, 24, and 36 months. AMs were diagnosed according to standardized criteria. Tolerance acquisition was evaluated every 12 months. RESULTS A total of 220 children (147 boys [67%]) with a median age of 5.0 months (interquartile range, 3.0-8.0 months) were randomized; 110 children were placed in the EHCF group, and 110 children were placed in the EHCF+LGG group. In the complete case analysis the absolute risk difference for the occurrence of at least 1 AM over 36 months was -0.23 (95% CI, -0.36 to -0.10; P < .001), and the absolute risk difference for the acquisition of cow's milk tolerance was 0.20 (95% CI, 0.05-0.35; P < .01) at 12 months, 0.24 (95% CI, 0.08-0.41; P < .01) at 24 months, and 0.27 (95% CI, 0.11-0.43; P < .001) at 36 months. In the sensitivity analysis the effect size of the main outcome was virtually unchanged when the occurrence of AMs was assigned to all 27 missing children. CONCLUSIONS EHCF+LGG reduces the incidence of other AMs and hastens the development of oral tolerance in children with IgE-mediated CMA.
Methodological quality
Allocation concealment
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