{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T20:50:55Z","timestamp":1790196655117,"version":"4.1.0"},"reference-count":24,"publisher":"BMJ","issue":"4","funder":[{"DOI":"10.13039\/501100001665","name":"Agence Nationale de la Recherche","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001665","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004571","name":"Minist\u00e8re des Affaires Sociales et de la Sant\u00e9","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004571","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,2,12]]},"published-print":{"date-parts":[[2019,4]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Atopic dermatitis (AD) is a chronic inflammatory disease affecting 10%\u201315% of children in Europe. There is a need for new primary preventive therapeutic strategies in at-risk populations. Recent research has indicated that atopic diseases are associated with a disrupted gut microbial \u2018balance\u2019 in early life raising the possibility that interventions which yield optimal patterns of microflora could improve host\u2019s health. Prebiotics, sugars with immunomodulatory properties that stimulate the diversity of the digestive microbiota, are ideal candidates for such research. So far, most clinical trials have focused on improving infant gut colonisation postnatally. However, prenatal life is a crucial period during which different tolerance mechanisms are put in place. We aim to determine whether antenatal prebiotics supplementation prevents AD in high-risk children.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This is a randomised, multicentre, double-blind, trial to evaluate the effectiveness of antenatal prebiotic maternal supplementation (galacto-oligosaccharide\/inulin) in pregnant women versus placebo on the occurrence of AD at 1\u2009year of age in at-risk children (defined as having a maternal history of atopic disease). Participating women will be randomised to daily ingestion of a prebiotics or placebo (maltodextrin) from 20 weeks\u2019 gestation until delivery. The primary outcome is the prevalence of AD at 1\u2009year of age, using the version of the UK Working Party Diagnostic Criteria optimised for preventive studies. Key secondary endpoints are AD severity, quality of life and prebiotics tolerance. The target sample size is 376 women (188 patients per group) which will provide 80% power to detect a 33% reduction of the risk of AD in the verum group (\u03b1=0.05). The primary analysis will be based on the intention-to-treat principle.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Results will be presented in peer-reviewed journals and at international conferences. Ethics approval for the study was obtained from the institutional ethical review board of \u2018Comit\u00e9 de Protection des Personnes Sud Ouest\u2014Outre-Mer III\u2019 of the University Hospital Centre of Bordeaux (2017\/13).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT03183440\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial pre-results\">NCT03183440<\/jats:ext-link>\n                      ; Pre-results.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2018-024974","type":"journal-article","created":{"date-parts":[[2019,4,20]],"date-time":"2019-04-20T12:19:47Z","timestamp":1555762787000},"page":"e024974","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":20,"title":["Effectiveness of an antenatal maternal supplementation with prebiotics for preventing atopic dermatitis in high-risk children (the PREGRALL study): protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"9","clinical-trial-number":[{"clinical-trial-number":"nct03183440","registry":"10.18810\/clinical-trials-gov","type":"preResults"}],"author":[{"given":"Cl\u00e9mentine","family":"Cabridain","sequence":"first","affiliation":[{"name":"UMR PhAN, INRA Centre Angers-Nantes, Nantes, Pays de la Loire, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H\u00e9l\u00e8ne","family":"Aubert","sequence":"additional","affiliation":[{"name":"Department of 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