Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Nov 23:8:47.
doi: 10.1186/s13601-018-0233-8. eCollection 2018.

Early aggressive intervention for infantile atopic dermatitis to prevent development of food allergy: a multicenter, investigator-blinded, randomized, parallel group controlled trial (PACI Study)-protocol for a randomized controlled trial

Kiwako Yamamoto-Hanada  1 , Tohru Kobayashi  2 , Hywel C Williams  3 , Masashi Mikami  4 , Mayako Saito-Abe  1 , Kumiko Morita  1   5 , Osamu Natsume  1   6 , Miori Sato  1 , Motoko Iwama  1 , Yumiko Miyaji  1 , Makiko Miyata  1 , Shinichiro Inagaki  1 , Fukuie Tatsuki  1 , Narita Masami  1 , Shoji F Nakayama  7 , Hiroshi Kido  8 , Hirohisa Saito  9 , Yukihiro Ohya  1
Affiliations

Early aggressive intervention for infantile atopic dermatitis to prevent development of food allergy: a multicenter, investigator-blinded, randomized, parallel group controlled trial (PACI Study)-protocol for a randomized controlled trial

Kiwako Yamamoto-Hanada et al. Clin Transl Allergy. .

Abstract

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.Trial registration UMIN-CTR: UMIN000028043.

Keywords: Atopic dermatitis; Food allergy; Infants; Prevention; Randomized controlled trial.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Trial scheme
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Deckers IAG, McLean S, Linssen S, et al. Investigating international time trends in the incidence and prevalence of atopic eczema 1990–2010: a systematic review of epidemiological studies. PLoS ONE. 2012;7(7):e39803. doi: 10.1371/journal.pone.0039803. - DOI - PMC - PubMed
    1. Ito J, Fujiwara T. Breastfeeding and risk of atopic dermatitis up to the age 42 months: a birth cohort study in Japan. Ann Epidemiol. 2014;24(4):267–272. doi: 10.1016/j.annepidem.2013.11.007. - DOI - PubMed
    1. Prescott S, Allen KJ. Food allergy: riding the second wave of the allergy epidemic. Pediatr Allergy Immunol. 2011;22(2):155–160. doi: 10.1111/j.1399-3038.2011.01145.x. - DOI - PubMed
    1. Ebisawa M, Nishima S, Ohnishi H, et al. Pediatric allergy and immunology in Japan. Pediatr Allergy Immunol. 2013;24(7):704–714. doi: 10.1111/pai.12117. - DOI - PubMed
    1. Shoda T, Futamura M, Yang L, et al. Timing of eczema onset and risk of food allergy at 3 years of age: a hospital-based prospective birth cohort study. J Dermatol Sci. 2016 doi: 10.1016/j.jdermsci.2016.08.003. - DOI - PubMed