Extensively hydrolyzed casein formula containing Lactobacillus rhamnosus GG reduces the occurrence of other allergic manifestations in children with cow's milk allergy: 3-year randomized controlled trial - 27/09/17
, Margherita Di Costanzo, MD a, Giorgio Bedogni, MD c, d, Antonio Amoroso, BS a, c, Linda Cosenza, MD a, Carmen Di Scala, LDN a, Viviana Granata, MD a, Rita Nocerino, RN a, cAbstract |
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.
Il testo completo di questo articolo è disponibile in PDF.Key words : Eczema, urticaria, asthma, rhinoconjunctivitis, atopic march, food allergy, gut microbiota, probiotics
Abbreviations used : AM, ARD, BRM, CCA, CMA, DBPCFC, EHCF, FA, FP, HDAC, IQR, LGG, RCT, SA-BCS, SA-EQS, SA-WCS, SPT
Mappa
| Supported in part by the Italian Ministry of Health (grant PE-2011-02348447) and an unrestricted grant from Mead Johnson Nutrition (Evansville, Ind) devoted to the Department of Translational Medical Science of the University of Naples “Federico II.” However, the Italian Ministry of Health and Mead Johnson Nutrition had no influence on (1) the study design; (2) the collection, analysis, and interpretation of the data; (3) the writing of the manuscript; or (4) the decision to submit the manuscript for publication. |
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| Disclosure of potential conflict of interest: All authors declare that all of their institutions have received grants from the Italian Ministry of Health (grant PE-2011-02348447) and an unrestricted grant from Mead Johnson Nutrition (Evansville, Ind) R. Berni Canani has received support for travel from Mead Johnson Nutrition. |
Vol 139 - N° 6
P. 1906 - giugno 2017 Ritorno al numero
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