Roberto Berni Canani1, Margherita Di Costanzo2, Giorgio Bedogni3, Antonio Amoroso4, Linda Cosenza2, Carmen Di Scala2, Viviana Granata2, Rita Nocerino4. 1. Department of Translational Medical Science, University of Naples "Federico II", Naples, Italy; European Laboratory for the Investigation of Food-Induced Diseases, University of Naples "Federico II", Naples, Italy; CEINGE Advanced Biotechnologies, University of Naples "Federico II", Naples, Italy. Electronic address: berni@unina.it. 2. Department of Translational Medical Science, University of Naples "Federico II", Naples, Italy. 3. CEINGE Advanced Biotechnologies, University of Naples "Federico II", Naples, Italy; Clinical Epidemiology Unit, Liver Research Center Basovizza, Trieste, Italy. 4. Department of Translational Medical Science, University of Naples "Federico II", Naples, Italy; CEINGE Advanced Biotechnologies, University of Naples "Federico II", Naples, Italy.
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.
RCT Entities:
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.
Authors: Cristobalina Mayorga; Francisca Palomares; José A Cañas; Natalia Pérez-Sánchez; Rafael Núñez; María José Torres; Francisca Gómez Journal: Foods Date: 2021-05-10
Authors: Benjamin Zepeda-Ortega; Anne Goh; Paraskevi Xepapadaki; Aline Sprikkelman; Nicolaos Nicolaou; Rosa Elena Huerta Hernandez; Amir Hamzah Abdul Latiff; Miu Ting Yat; Mohamed Diab; Bakr Al Hussaini; Budi Setiabudiawan; Urszula Kudla; R J Joost van Neerven; Leilani Muhardi; John O Warner Journal: Front Immunol Date: 2021-06-10 Impact factor: 7.561