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Open Access 01-12-2018 | Study protocol

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

Authors: Kiwako Yamamoto-Hanada, Tohru Kobayashi, Hywel C. Williams, Masashi Mikami, Mayako Saito-Abe, Kumiko Morita, Osamu Natsume, Miori Sato, Motoko Iwama, Yumiko Miyaji, Makiko Miyata, Shinichiro Inagaki, Fukuie Tatsuki, Narita Masami, Shoji F. Nakayama, Hiroshi Kido, Hirohisa Saito, Yukihiro Ohya

Published in: Clinical and Translational Allergy | Issue 1/2018

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

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Title: 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
Authors: Kiwako Yamamoto-Hanada
Tohru Kobayashi
Hywel C. Williams
Masashi Mikami
Mayako Saito-Abe
Kumiko Morita
Osamu Natsume
Miori Sato
Motoko Iwama
Yumiko Miyaji
Makiko Miyata
Shinichiro Inagaki
Fukuie Tatsuki
Narita Masami
Shoji F. Nakayama
Hiroshi Kido
Hirohisa Saito
Yukihiro Ohya
Publication date: 01-12-2018
Publisher: BioMed Central
Published in: Clinical and Translational Allergy / Issue 1/2018
Electronic ISSN: 2045-7022
DOI: https://doi.org/10.1186/s13601-018-0233-8

At a glance: The STEP trials

Springer Medicine

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

Abstract

Background

Methods

Discussion

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Discussion

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