Yamamoto‑Hanada, Kiwako National Center for Child Health and Development
Kobayashi, Tohru National Center for Child Health and Development
Williams, Hywel C. University of Nottingham
Mikami, Masashi National Center for Child Health and Development
Saito‑Abe, Mayako National Center for Child Health and Development
Morita, Kumiko National Center for Child Health and Development|Keio University
Natsume, Osamu National Center for Child Health and Development|Hamamatsu University School of Medicine
Sato, Miori National Center for Child Health and Development
Iwama, Motoko National Center for Child Health and Development
Miyaji, Yumiko National Center for Child Health and Development
Miyata, Makiko National Center for Child Health and Development
Inagaki, Shinichiro National Center for Child Health and Development
Fukuie, Tatsuki National Center for Child Health and Development
Narita, Masami National Center for Child Health and Development
Nakayama, Shoji F. National Institute for Environmental Studies
Kido, Hiroshi Tokushima University Tokushima University Educator and Researcher Directory KAKEN Search Researchers
Saito, Hirohisa National Research Institute for Child Health and Development
Ohya, Yukihiro National Center for Child Health and Development
Randomized controlled trial
Background: Atopic dermatitis is the first clinical manifestation of the atopic march, with the highest incidence in the first year of life. Those affected often go on to develop other allergic diseases including food allergy, asthma, and allergic rhinitis. Recent evidence suggests that sensitization to foods may occur through a defective skin barrier which is common in atopic dermatitis in early life. We hypothesize that therapeutic aggressive intervention to treat new onset atopic dermatitis may prevent the development of later allergen sensitization, and associated food allergy, asthma, and allergic rhinitis.
Methods: This study is a multi-center, pragmatic, two-parallel group, assessor-blind, superiority, individually randomized controlled trial. Atopic dermatitis infants (N = 650) 7–13 weeks old who develop an itchy rash within the previous 28 days are randomly assigned to the aggressive treatment or the conventional treatment in a 1:1 ratio. The primary outcome is oral food challenge-proven IgE-mediated hen’s egg allergy at the age of 28 weeks.
Discussion: This is a novel pragmatic RCT study to examine the efficacy of early aggressive treatment for atopic dermatitis to prevent later food allergy. If our hypothesis is correct, we hope that such a strategy might impact on disease prevention in countries where food allergy is common, and that our results might reduce the frequency and associated costs of all food allergies as well as hens egg food allergy. Long-term follow and other similar studies will help to determine whether such a strategy will reduce the burden of other allergic diseases such as asthma and allergic rhinitis.
Clinical and Translational Allergy
Springer Nature|BioMed Central
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Institute of Advanced Medical Sciences