{
  "abstract": "Introduction The predisposition to food allergy development and the induction of allergen-specific immune responses appears to be initiated early in infancy. Early exposure to food allergens, such as peanut and cashew nut, via human milk is likely important in initiating oral tolerance and reducing risk of food allergy development. This trial aims to determine if the risk of developing peanut and cashew nut allergy during infancy can be reduced by a high peanut and cashew nut maternal diet during lactation.Methods and analysis This is a multisite, parallel, two-arm (1:1 allocation), single-blinded (outcome assessors, statistical analyst and investigators), randomised controlled trial. Target sample size is 4412 participants (2206 per group). Women (aged 18–50 years) with a singleton pregnancy, who are planning to breastfeed and do not have peanut and/or cashew nut allergies are eligible to participate. After obtaining written informed consent, participants are randomised to either a high peanut and cashew nut diet (at least 60 peanuts and 40 cashew nuts per week) or a low peanut and cashew nut diet (no more than 20 peanuts and 12 cashew nuts per week). Participants are asked to follow their allocated diet from birth to 6 months postnatal. Individual lactation consultant advice and support is provided as required. The study’s primary outcome is food challenge proven IgE-mediated peanut and/or cashew nut allergy during infancy (0–18 months). Key secondary outcomes include infant sensitisation to peanut and/or cashew nut. Analyses will be performed on an intention-to-treat basis according to a prespecified statistical analysis plan.Ethics and dissemination Ethical approval has been granted from the Western Australian Child and Adolescent Health Service Human Research Ethics Committee (approval number RGS0000006685). Trial results will be presented at scientific conferences and published in peer-reviewed journals.Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN ACTRN12624000134527)",
  "authors": [
    {
      "affiliations": [
        "SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia",
        "School of Public Health, The University of Adelaide, Adelaide, South Australia, Australia"
      ],
      "name": "Thomas R Sullivan"
    },
    {
      "affiliations": [
        "Centre for Food Allergy Research, Murdoch Childrens Research Institute, Parkville, Victoria, Australia",
        "Department of Allergy and Immunology, The Royal Children’s Hospital Melbourne, Parkville, Victoria, Australia",
        "Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia",
        "National Allergy Centre of Excellence, Murdoch Children’s Research Institute, Parkville, Victoria, Australia"
      ],
      "name": "Vicki McWilliam"
    },
    {
      "affiliations": [
        "National Allergy Centre of Excellence, Murdoch Children’s Research Institute, Parkville, Victoria, Australia",
        "Immunology Department, Perth Children’s Hospital, Nedlands, Western Australia, Australia",
        "School of Medicine, The University of Western Australia, Perth, Western Australia, Australia",
        "The Kids Research Institute Australia, Nedlands, Western Australia, Australia"
      ],
      "name": "Michael O’Sullivan"
    },
    {
      "affiliations": [
        "Centre for Food Allergy Research, Murdoch Childrens Research Institute, Parkville, Victoria, Australia",
        "School of Medicine, The University of Adelaide, Adelaide, South Australia, Australia"
      ],
      "name": "Merryn Netting"
    },
    {
      "affiliations": [
        "School of Molecular Sciences, The University of Western Australia, Perth, Western Australia, Australia",
        "Centre for Human Lactation Research and Translation, The University of Western Australia, Perth, Western Australia, Australia"
      ],
      "name": "Sharon Perrella"
    },
    {
      "affiliations": [
        "School of Molecular Sciences, The University of Western Australia, Perth, Western Australia, Australia",
        "Centre for Human Lactation Research and Translation, The University of Western Australia, Perth, Western Australia, Australia"
      ],
      "name": "Donna Geddes"
    },
    {
      "affiliations": [
        "Centre for Food Allergy Research, Murdoch Childrens Research Institute, Parkville, Victoria, Australia",
        "Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia",
        "Murdoch Children’s Research Institute, Parkville, Victoria, Australia",
        "Department of Allergy and Immunology, The Royal Children’s Hospital Melbourne, Melbourne, Victoria, Australia"
      ],
      "name": "Mimi Tang"
    },
    {
      "affiliations": [
        "Centre for Food Allergy Research, Murdoch Childrens Research Institute, Parkville, Victoria, Australia",
        "National Allergy Centre of Excellence, Murdoch Children’s Research Institute, Parkville, Victoria, Australia",
        "Specialty of Child and Adolescent Health, Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia",
        "Department of Allergy and Immunology, The Children’s Hospital at Westmead, Sydney, New South Wales, Australia"
      ],
      "name": "Dianne E Campbell"
    },
    {
      "affiliations": [
        "Centre for Food Allergy Research, Murdoch Childrens Research Institute, Parkville, Victoria, Australia",
        "Department of Allergy and Immunology, The Royal Children’s Hospital Melbourne, Parkville, Victoria, Australia",
        "Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia",
        "National Allergy Centre of Excellence, Murdoch Children’s Research Institute, Parkville, Victoria, Australia"
      ],
      "name": "Kirsten P Perrett"
    },
    {
      "affiliations": [
        "Centre for Food Allergy Research, Murdoch Childrens Research Institute, Parkville, Victoria, Australia",
        "School of Medicine, The University of Western Australia, Perth, Western Australia, Australia",
        "Centre for Human Lactation Research and Translation, The University of Western Australia, Perth, Western Australia, Australia",
        "Nutrition In Early Life, The Kids Research Institute Australia, Nedlands, Western Australia, Australia"
      ],
      "name": "Debra J Palmer"
    }
  ],
  "title": "Nuts For Babies Study: protocol for a randomised controlled trial in Australia investigating if the risk of developing peanut and cashew nut allergies during infancy can be reduced by a high peanut and cashew nut maternal diet for the first 6 months of lactation",
  "uid": "5c3955ac-3f86-5b74-8a00-b0abc11f2afa"
}