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

Children with cow's milk allergy (CMA) have an increased risk of other allergic manifestations (AMs). 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 (LG...

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Published in:Journal of allergy and clinical immunology 2017-06, Vol.139 (6), p.1906-1913.e4
Main Authors: Berni Canani, Roberto, Di Costanzo, Margherita, Bedogni, Giorgio, Amoroso, Antonio, Cosenza, Linda, Di Scala, Carmen, Granata, Viviana, Nocerino, Rita
Format: Article
Language:English
Subjects:
Allergies
Asthma
Asthma - immunology
Asthma - therapy
atopic march
Casein
Caseins - therapeutic use
Children
Chronic illnesses
Clinical trials
Conjunctivitis - immunology
Conjunctivitis - therapy
Cow's milk
Diet
Dietitians
Double-Blind Method
Eczema
Eczema - immunology
Eczema - therapy
Epigenetics
Families & family life
Female
Food
Food allergies
food allergy
Food, Formulated
Gene expression
gut microbiota
Humans
Hydrolysis
Immune Tolerance
Immunoglobulin E
Immunoglobulin E - immunology
Incidence
Infant
Lactobacillus rhamnosus
Male
Milk
Milk Hypersensitivity - immunology
Milk Hypersensitivity - therapy
Nutrition research
Parents & parenting
probiotics
Probiotics - therapeutic use
Randomization
Rhinitis, Allergic - immunology
Rhinitis, Allergic - therapy
Rhinoconjunctivitis
Sensitivity analysis
Skin diseases
Skin Tests
Urticaria
Urticaria - immunology
Urticaria - therapy
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creator Berni Canani, Roberto
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Nocerino, Rita
description Children with cow's milk allergy (CMA) have an increased risk of other allergic manifestations (AMs). 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. 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. 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 
doi_str_mv 10.1016/j.jaci.2016.10.050
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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. 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. 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 &lt; .001), and the absolute risk difference for the acquisition of cow's milk tolerance was 0.20 (95% CI, 0.05-0.35; P &lt; .01) at 12 months, 0.24 (95% CI, 0.08-0.41; P &lt; .01) at 24 months, and 0.27 (95% CI, 0.11-0.43; P &lt; .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. EHCF+LGG reduces the incidence of other AMs and hastens the development of oral tolerance in children with IgE-mediated CMA.</description><identifier>ISSN: 0091-6749</identifier><identifier>EISSN: 1097-6825</identifier><identifier>DOI: 10.1016/j.jaci.2016.10.050</identifier><identifier>PMID: 28043872</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Allergies ; Asthma ; Asthma - immunology ; Asthma - therapy ; atopic march ; Casein ; Caseins - therapeutic use ; Children ; Chronic illnesses ; Clinical trials ; Conjunctivitis - immunology ; Conjunctivitis - therapy ; Cow's milk ; Diet ; Dietitians ; Double-Blind Method ; Eczema ; Eczema - immunology ; Eczema - therapy ; Epigenetics ; Families &amp; family life ; Female ; Food ; Food allergies ; food allergy ; Food, Formulated ; Gene expression ; gut microbiota ; Humans ; Hydrolysis ; Immune Tolerance ; Immunoglobulin E ; Immunoglobulin E - immunology ; Incidence ; Infant ; Lactobacillus rhamnosus ; Male ; Milk ; Milk Hypersensitivity - immunology ; Milk Hypersensitivity - therapy ; Nutrition research ; Parents &amp; parenting ; probiotics ; Probiotics - therapeutic use ; Randomization ; Rhinitis, Allergic - immunology ; Rhinitis, Allergic - therapy ; Rhinoconjunctivitis ; Sensitivity analysis ; Skin diseases ; Skin Tests ; Urticaria ; Urticaria - immunology ; Urticaria - therapy</subject><ispartof>Journal of allergy and clinical immunology, 2017-06, Vol.139 (6), p.1906-1913.e4</ispartof><rights>2017 The Authors</rights><rights>Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.</rights><rights>Copyright Elsevier Science Ltd. Jun 1, 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c428t-de1b16002c92286010914b5ed9ff61c28821b9d275e7e9fd3b6671cb48552b4d3</citedby><cites>FETCH-LOGICAL-c428t-de1b16002c92286010914b5ed9ff61c28821b9d275e7e9fd3b6671cb48552b4d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28043872$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Berni Canani, Roberto</creatorcontrib><creatorcontrib>Di Costanzo, Margherita</creatorcontrib><creatorcontrib>Bedogni, Giorgio</creatorcontrib><creatorcontrib>Amoroso, Antonio</creatorcontrib><creatorcontrib>Cosenza, Linda</creatorcontrib><creatorcontrib>Di Scala, Carmen</creatorcontrib><creatorcontrib>Granata, Viviana</creatorcontrib><creatorcontrib>Nocerino, Rita</creatorcontrib><title>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</title><title>Journal of allergy and clinical immunology</title><addtitle>J Allergy Clin Immunol</addtitle><description>Children with cow's milk allergy (CMA) have an increased risk of other allergic manifestations (AMs). 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. 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. 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 &lt; .001), and the absolute risk difference for the acquisition of cow's milk tolerance was 0.20 (95% CI, 0.05-0.35; P &lt; .01) at 12 months, 0.24 (95% CI, 0.08-0.41; P &lt; .01) at 24 months, and 0.27 (95% CI, 0.11-0.43; P &lt; .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. EHCF+LGG reduces the incidence of other AMs and hastens the development of oral tolerance in children with IgE-mediated CMA.</description><subject>Allergies</subject><subject>Asthma</subject><subject>Asthma - immunology</subject><subject>Asthma - therapy</subject><subject>atopic march</subject><subject>Casein</subject><subject>Caseins - therapeutic use</subject><subject>Children</subject><subject>Chronic illnesses</subject><subject>Clinical trials</subject><subject>Conjunctivitis - immunology</subject><subject>Conjunctivitis - therapy</subject><subject>Cow's milk</subject><subject>Diet</subject><subject>Dietitians</subject><subject>Double-Blind Method</subject><subject>Eczema</subject><subject>Eczema - immunology</subject><subject>Eczema - therapy</subject><subject>Epigenetics</subject><subject>Families &amp; family life</subject><subject>Female</subject><subject>Food</subject><subject>Food allergies</subject><subject>food allergy</subject><subject>Food, Formulated</subject><subject>Gene expression</subject><subject>gut microbiota</subject><subject>Humans</subject><subject>Hydrolysis</subject><subject>Immune Tolerance</subject><subject>Immunoglobulin E</subject><subject>Immunoglobulin E - immunology</subject><subject>Incidence</subject><subject>Infant</subject><subject>Lactobacillus rhamnosus</subject><subject>Male</subject><subject>Milk</subject><subject>Milk Hypersensitivity - immunology</subject><subject>Milk Hypersensitivity - therapy</subject><subject>Nutrition research</subject><subject>Parents &amp; parenting</subject><subject>probiotics</subject><subject>Probiotics - therapeutic use</subject><subject>Randomization</subject><subject>Rhinitis, Allergic - immunology</subject><subject>Rhinitis, Allergic - therapy</subject><subject>Rhinoconjunctivitis</subject><subject>Sensitivity analysis</subject><subject>Skin diseases</subject><subject>Skin Tests</subject><subject>Urticaria</subject><subject>Urticaria - immunology</subject><subject>Urticaria - therapy</subject><issn>0091-6749</issn><issn>1097-6825</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><recordid>eNp9kcFu1DAQhiMEotvCC3BAljjQSxbbSZwE9YKqsiCtxAXOlmNPGi-OXeykJbwiL8WEXThw4OTfo29mfvvPsheMbhll4s1he1DabjlqLGxpRR9lG0bbOhcNrx5nG0pblou6bM-y85QOFO9F0z7NznhDy6Kp-Sb7efN9Ap_sPbiFDIuJwS0_wBCtElhP-hDH2Smig5-U9dbfkr3SU-hwsXNzInFQow8J1W5HIphZQyLTACRoPccIXqPsScBSJMo5iLdWk1F520Oa1GSDTwQX6cE6gzh5sNOA6x5eJzJa9_XUs7wlRb6AiiQqb8Jof3tEU-jXoZyiVe5Z9qRXLsHz03mRfXl_8_n6Q77_tPt4_W6f65I3U26AdUxQynXLeSMo_hgruwpM2_eCad40nHWt4XUFNbS9KTohaqa7sqkq3pWmuMguj3PvYvg24zPkaJMG55SHMCfJEKSiKgVD9NU_6CHM0aM7yVpaNgWvCo4UP1I6hpQi9PIu2lHFRTIq16jlQa5RyzXqtYZRY9PL0-i5G8H8bfmTLQJXRwDwL-4tRJm0XQMxNoKepAn2f_N_Aae0vuc</recordid><startdate>201706</startdate><enddate>201706</enddate><creator>Berni Canani, Roberto</creator><creator>Di Costanzo, Margherita</creator><creator>Bedogni, Giorgio</creator><creator>Amoroso, Antonio</creator><creator>Cosenza, Linda</creator><creator>Di Scala, Carmen</creator><creator>Granata, Viviana</creator><creator>Nocerino, Rita</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7SS</scope><scope>7T5</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope></search><sort><creationdate>201706</creationdate><title>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</title><author>Berni Canani, Roberto ; Di Costanzo, Margherita ; Bedogni, Giorgio ; Amoroso, Antonio ; Cosenza, Linda ; Di Scala, Carmen ; Granata, Viviana ; Nocerino, Rita</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c428t-de1b16002c92286010914b5ed9ff61c28821b9d275e7e9fd3b6671cb48552b4d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Allergies</topic><topic>Asthma</topic><topic>Asthma - immunology</topic><topic>Asthma - therapy</topic><topic>atopic march</topic><topic>Casein</topic><topic>Caseins - therapeutic use</topic><topic>Children</topic><topic>Chronic illnesses</topic><topic>Clinical trials</topic><topic>Conjunctivitis - immunology</topic><topic>Conjunctivitis - therapy</topic><topic>Cow's milk</topic><topic>Diet</topic><topic>Dietitians</topic><topic>Double-Blind Method</topic><topic>Eczema</topic><topic>Eczema - immunology</topic><topic>Eczema - therapy</topic><topic>Epigenetics</topic><topic>Families &amp; family life</topic><topic>Female</topic><topic>Food</topic><topic>Food allergies</topic><topic>food allergy</topic><topic>Food, Formulated</topic><topic>Gene expression</topic><topic>gut microbiota</topic><topic>Humans</topic><topic>Hydrolysis</topic><topic>Immune Tolerance</topic><topic>Immunoglobulin E</topic><topic>Immunoglobulin E - immunology</topic><topic>Incidence</topic><topic>Infant</topic><topic>Lactobacillus rhamnosus</topic><topic>Male</topic><topic>Milk</topic><topic>Milk Hypersensitivity - immunology</topic><topic>Milk Hypersensitivity - therapy</topic><topic>Nutrition research</topic><topic>Parents &amp; parenting</topic><topic>probiotics</topic><topic>Probiotics - therapeutic use</topic><topic>Randomization</topic><topic>Rhinitis, Allergic - immunology</topic><topic>Rhinitis, Allergic - therapy</topic><topic>Rhinoconjunctivitis</topic><topic>Sensitivity analysis</topic><topic>Skin diseases</topic><topic>Skin Tests</topic><topic>Urticaria</topic><topic>Urticaria - immunology</topic><topic>Urticaria - therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Berni Canani, Roberto</creatorcontrib><creatorcontrib>Di Costanzo, Margherita</creatorcontrib><creatorcontrib>Bedogni, Giorgio</creatorcontrib><creatorcontrib>Amoroso, Antonio</creatorcontrib><creatorcontrib>Cosenza, Linda</creatorcontrib><creatorcontrib>Di Scala, Carmen</creatorcontrib><creatorcontrib>Granata, Viviana</creatorcontrib><creatorcontrib>Nocerino, Rita</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; 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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. 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. 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 &lt; .001), and the absolute risk difference for the acquisition of cow's milk tolerance was 0.20 (95% CI, 0.05-0.35; P &lt; .01) at 12 months, 0.24 (95% CI, 0.08-0.41; P &lt; .01) at 24 months, and 0.27 (95% CI, 0.11-0.43; P &lt; .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. EHCF+LGG reduces the incidence of other AMs and hastens the development of oral tolerance in children with IgE-mediated CMA.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>28043872</pmid><doi>10.1016/j.jaci.2016.10.050</doi><oa>free_for_read</oa></addata></record>
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source ScienceDirect Journals
subjects Allergies
Asthma
Asthma - immunology
Asthma - therapy
atopic march
Casein
Caseins - therapeutic use
Children
Chronic illnesses
Clinical trials
Conjunctivitis - immunology
Conjunctivitis - therapy
Cow's milk
Diet
Dietitians
Double-Blind Method
Eczema
Eczema - immunology
Eczema - therapy
Epigenetics
Families & family life
Female
Food
Food allergies
food allergy
Food, Formulated
Gene expression
gut microbiota
Humans
Hydrolysis
Immune Tolerance
Immunoglobulin E
Immunoglobulin E - immunology
Incidence
Infant
Lactobacillus rhamnosus
Male
Milk
Milk Hypersensitivity - immunology
Milk Hypersensitivity - therapy
Nutrition research
Parents & parenting
probiotics
Probiotics - therapeutic use
Randomization
Rhinitis, Allergic - immunology
Rhinitis, Allergic - therapy
Rhinoconjunctivitis
Sensitivity analysis
Skin diseases
Skin Tests
Urticaria
Urticaria - immunology
Urticaria - therapy
title 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
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