Administration of a probiotic with peanut oral immunotherapy: A randomized trial - 05/03/15
, Anne-Louise Ponsonby, PhD d, Francesca Orsini, MSc e, Dean Tey, FRACP a, c, Marnie Robinson, FRACP a, c, Ee Lyn Su, FRACP a, c, Paul Licciardi, PhD c, Wesley Burks, MD f, Susan Donath, MA b, eAbstract |
Background |
Coadministration of a bacterial adjuvant with oral immunotherapy (OIT) has been suggested as a potential treatment for food allergy.
Objective |
To evaluate a combined therapy comprising a probiotic together with peanut OIT.
Methods |
We performed a double-blind, placebo-controlled randomized trial of the probiotic Lactobacillus rhamnosus CGMCC 1.3724 and peanut OIT (probiotic and peanut oral immunotherapy [PPOIT]) in children (1-10 years) with peanut allergy. The primary outcome was induction of sustained unresponsiveness 2 to 5 weeks after discontinuation of treatment (referred to as possible sustained unresponsiveness). Secondary outcomes were desensitization, peanut skin prick test, and specific IgE and specific IgG4 measurements.
Results |
Sixty-two children were randomized and stratified by age (≤5 and >5 years) and peanut skin test wheal size (≤10 and >10 mm); 56 reached the trial's end. Baseline demographics were similar across groups. Possible sustained unresponsiveness was achieved in 82.1% receiving PPOIT and 3.6% receiving placebo (P < .001). Nine children need to be treated for 7 to achieve sustained unresponsiveness (number needed to treat, 1.27; 95% CI, 1.06-1.59). Of the subjects, 89.7% receiving PPOIT and 7.1% receiving placebo were desensitized (P < .001). PPOIT was associated with reduced peanut skin prick test responses and peanut-specific IgE levels and increased peanut-specific IgG4 levels (all P < .001). PPOIT-treated participants reported a greater number of adverse events, mostly with maintenance home dosing.
Conclusion |
This is the first randomized placebo-controlled trial evaluating the novel coadministration of a probiotic and peanut OIT and assessing sustained unresponsiveness in children with peanut allergy. PPOIT was effective in inducing possible sustained unresponsiveness and immune changes that suggest modulation of the peanut-specific immune response. Further work is required to confirm sustained unresponsiveness after a longer period of secondary peanut elimination and to clarify the relative contributions of probiotics versus OIT.
Le texte complet de cet article est disponible en PDF.Key words : Peanut allergy, oral immunotherapy, probiotic, immune-modifying adjuvant, tolerance, sustained unresponsiveness, desensitization, peanut-specific IgE, peanut-specific IgG4
Abbreviations used : AE, DBPCFC, FDA, IQR, NIAID, NNT, OIT, OR, PPOIT, RCH, RCT, RR, SAE, sIgE, sIgG4, SPT
Plan
| Supported by the Food Allergy and Anaphylaxis Network (FAAN), the Murdoch Childrens Research Institute, Perpetual Philanthropy (grant ID 493), the CASS Foundation, the Financial Markets Foundation for Children and the National Health and Medical Research Council Australia (NHMRC project grant no. 1029690). Nestlè Health Science were provided a copy of the final draft before submission (as required by a Material Transfer Agreement). |
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| Disclosure of potential conflict of interest: M. L. K. Tang has received research support from the National Health and Medical Research Council Australia (NHMRC grant no. 1029690), the Murdoch Children's Research Institute, Perpetual Trustees (grant ID 493), the CASS Foundation, Financial Markets Foundation for Children, and the Food Allergy and Anaphylaxis Network; is a member of the Scientific Advisory Board on Immunity and Allergy and a member of the Medical Advisory Board Australia New Zealand for Danone Nutricia; is a member of the Medical Advisory Board Oceania for Nestlè Nutrition Institute; has received speakers' fees from Danone Nutricia; and has received travel support from the IUIS Primary Immune Deficiency Expert Committee and the World Allergy Organization. W. Burks is a board member for the Food Allergy Initiative, the Journal of Allergy and Clinical Immunology, the Food and Drug Administration, Food Allergy Research and Education, and the American Academy of Allergy, Asthma & Immunology; serves on the grant review board for the a National Institutes of Health Study Section; has consultant arrangements with Abbott Laboratories, Dow AgroSciences, McNeill Nutritionals, Merck, Novartis Pharma AG, Schering Plough, Unilever, ExploraMed Development, Nordic Biotech Advisors, Nutricia North America, Perrigo Company, Portola Pharmaceuticals, Regeneron Pharmaceuticals, Perosphere, ActoGenIX, SRA International, Genentech, and Sanofi US Services; is employed by Duke University and the University of North Carolina–Chapel Hill; has received research support from the National Institutes of Health (grant no. 5R01-AI-068074-09) and the Wallace Research Foundation; has received payment for lectures from Mylan Specialty and Levine's Children's Hospital; has received stock in Allertein; has received personal fees from GLG Research; is a minority stockholder in Mastcell Pharmaceuticals; and was a 2012 participant in Orange Ridge Associated Universities. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 135 - N° 3
P. 737 - mars 2015 Retour au numéro
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