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      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

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          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

          Electronic supplementary material

          The online version of this article (10.1186/s13601-018-0233-8) contains supplementary material, which is available to authorized users.

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          Most cited references 28

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          The U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis. III. Independent hospital validation.

          In order to qualify as a case of atopic dermatitis, we propose that an individual must have an itchy skin condition plus three or more of the following: history of flexural involvement, a history of asthma/hay fever, a history of a generalized dry skin, onset of rash under the age of 2 years, or visible flexural dermatitis. When tested in an independent sample of 200 consecutive dermatology outpatients of all ages, this arrangement of the diagnostic criteria achieved 69% sensitivity and 96% specificity when validated against physician's diagnosis. Based on the findings of this first exercise, minor modifications in the wording of the criteria were undertaken, and these were tested on a sample of 114 consecutive children attending out-patient paediatric dermatology clinics. Overall discrimination improved, with a sensitivity of 85% and specificity of 96%. The simplified criteria are easy to use, take under 2 min per patient to ascertain, and do not require subjects to undress. These two independent validation studies suggest that the newly proposed criteria for atopic dermatitis perform reasonably well in hospital out-patient patients. Further validation in community settings and in developing countries is needed.
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            The epidemiology of food allergy in Europe: a systematic review and meta-analysis.

            Food allergy (FA) is an important atopic disease although its precise burden is unclear. This systematic review aimed to provide recent, up-to-date data on the incidence, prevalence, time trends, and risk and prognostic factors for FA in Europe. We searched four electronic databases, covering studies published from 1 January 2000 to 30 September 2012. Two independent reviewers appraised the studies and qualified the risk of bias using the Critical Appraisal Skills Programme tool. Seventy-five eligible articles (comprising 56 primary studies) were included in a narrative synthesis, and 30 studies in a random-effects meta-analysis. Most of the studies were graded as at moderate risk of bias. The pooled lifetime and point prevalence of self-reported FA were 17.3% (95% CI: 17.0-17.6) and 5.9% (95% CI: 5.7-6.1), respectively. The point prevalence of sensitization to ≥1 food as assessed by specific IgE was 10.1% (95% CI: 9.4-10.8) and skin prick test 2.7% (95% CI: 2.4-3.0), food challenge positivity 0.9% (95% CI: 0.8-1.1). While the incidence of FA appeared stable over time, there was some evidence that the prevalence may be increasing. There were no consistent risk or prognostic factors for the development or resolution of FA identified, but sex, age, country of residence, familial atopic history, and the presence of other allergic diseases seem to be important. Food allergy is a significant clinical problem in Europe. The evidence base in this area would benefit from additional studies using standardized, rigorous methodology; data are particularly required from Eastern and Southern Europe. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
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              The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective.

              To develop a simple, valid, repeatable, and readily understandable patient-oriented assessment measure for monitoring disease activity in children and adults with atopic eczema. Qualitative semistructured patient interviews identified a list of symptoms of atopic eczema. These symptoms were quantitatively analyzed in a larger patient population to identify which symptoms were important to patients and amenable to monitoring as part of a scoring system. The outpatient Department of Dermatology at the Queen's Medical Centre, University Hospital, Nottingham, England, and 5 local general practices. Four hundred thirty-five patients with atopic eczema. Seven symptoms were incorporated into the final patient-oriented eczema measure using a simple 5-point scale of frequency of occurrence during the previous week, with a maximum total score of 28. Validity testing against the Dermatology Life Quality Index, Children's Dermatology Life Quality Index, and patients' global severity assessments showed good correlation (r = 0.78, r = 0.73, and r = 0.81, respectively; P<.001). Internal consistency was high (Cronbach alpha = 0.88), and test-retest reliability was good, with 95% of scores falling within 2.6 points on repeat testing (mean score difference, 0.04; SD, 1.32). Individual variables in the measure demonstrated sensitivity to change during a 4-week in-clinic period and an 18-week randomized controlled clinical trial. The patient-oriented eczema measure is a practical self-assessed measurement tool for monitoring aspects of atopic eczema that are important to patients in routine clinical practice or in the clinical trial setting.
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                Author and article information

                Contributors
                yamamoto-k@ncchd.go.jp
                kobayashi-tr@ncchd.go.jp
                Hywel.Williams@nottingham.ac.uk
                mikami-ms@ncchd.go.jp
                saito-myk@ncchd.go.jp
                morita-k@keio.jp
                natsumeo@hama-med.ac.jp
                sato-m@ncchd.go.jp
                mitsui-m@ncchd.go.jp
                miyaji-y@ncchd.go.jp
                miyata-m@ncchd.go.jp
                inagaki-s@ncchd.go.jp
                fukuie-t@ncchd.go.jp
                narita-m@ncchd.go.jp
                fabre@nies.go.jp
                kido@tokushima-u.ac.jp
                saito-hr@ncchd.go.jp
                +81-3-3416-0181 , ohya-y@ncchd.go.jp
                Journal
                Clin Transl Allergy
                Clin Transl Allergy
                Clinical and Translational Allergy
                BioMed Central (London )
                2045-7022
                23 November 2018
                23 November 2018
                2018
                : 8
                Affiliations
                [1 ]ISNI 0000 0004 0377 2305, GRID grid.63906.3a, Allergy Center, , National Center for Child Health and Development, ; 2-10-1, Okura, Setagaya-ku, Tokyo, 157-8535 Japan
                [2 ]ISNI 0000 0004 0377 2305, GRID grid.63906.3a, Department of Management and Strategy, Clinical Research Center, , National Center for Child Health and Development, ; Tokyo, Japan
                [3 ]ISNI 0000 0004 1936 8868, GRID grid.4563.4, Centre of Evidence-Based Dermatology, , University of Nottingham, ; Nottingham, UK
                [4 ]ISNI 0000 0004 0377 2305, GRID grid.63906.3a, Division of Biostatistics, Clinical Research Center, , National Center for Child Health and Development, ; Tokyo, Japan
                [5 ]ISNI 0000 0004 1936 9959, GRID grid.26091.3c, Department of Pediatrics, School of Medicine, , Keio University, ; Tokyo, Japan
                [6 ]ISNI 0000 0004 1762 0759, GRID grid.411951.9, Department of Pediatrics, , Hamamatsu University School of Medicine, ; Shizuoka, Japan
                [7 ]ISNI 0000 0001 0746 5933, GRID grid.140139.e, Centre for Health and Environmental Risk Research, , National Institute for Environmental Studies, ; Ibaraki, Japan
                [8 ]ISNI 0000 0001 1092 3579, GRID grid.267335.6, Division of Enzyme Chemistry, Institute of Enzyme Research, , Tokushima University, ; Tokushima, Japan
                [9 ]ISNI 0000 0004 0377 2305, GRID grid.63906.3a, Department of Allergy and Clinical Immunology, , National Research Institute for Child Health and Development, ; Tokyo, Japan
                Article
                233
                10.1186/s13601-018-0233-8
                6251129
                © The Author(s) 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Funding
                Funded by: The Japan Agency for Medical Research and Development (AMED)
                Award ID: 16768305
                Award Recipient :
                Funded by: he Japan Agency for Medical Research and Development (AMED)
                Award ID: 17930508
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Immunology

                randomized controlled trial, atopic dermatitis, prevention, food allergy, infants

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