{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T06:31:43Z","timestamp":1783751503497,"version":"3.55.0"},"reference-count":56,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2018,5,29]],"date-time":"2018-05-29T00:00:00Z","timestamp":1527552000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100001665","name":"Agence Nationale de la Recherche","doi-asserted-by":"publisher","award":["RBHP2013 Fauquert"],"award-info":[{"award-number":["RBHP2013 Fauquert"]}],"id":[{"id":"10.13039\/501100001665","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Experimental Allergy"],"published-print":{"date-parts":[[2018,7]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Oral immunotherapy to peanut is effective in desensitizing patients but has significant side effects including anaphylaxis and gastrointestinal symptoms. In most protocols, peanut is administered in a vehicle food.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>In an exclusively adolescent population, we tested a new approach using sealed capsules of peanut (gastrointestinal delivery oral immunotherapy or GIDOIT) to bypass the upper gastrointestinal tract. The primary aim was to assess the efficacy of the oral build\u2010up phase of GIDOIT and the secondary aim to analyse its safety.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Adolescents with a history of a clinical allergic reaction after peanut ingestion were included in a 2\u2010armed, parallel\u2010design, individually randomized, double\u2010blind, placebo\u2010controlled, multicentre trial after a positive double\u2010blind placebo\u2010controlled oral food challenge (DBPCFC1). A central randomization centre used computer\u2010generated tables to allocate treatments. Peanut (or placebo) capsules were ingested daily over a period of 24\u00a0weeks with increments every 2\u00a0weeks from 2 to 400\u00a0mg of peanut protein (pp). Primary outcome was tolerance of 400\u00a0mg of pp at DBPCFC2.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Thirty patients were included between September 2013 and May 2014. At DBPCFC2, unresponsiveness to 400\u00a0mg of pp was achieved in 17\/21 peanut group patients (2 withdrawn patients) and 1\/9 in the placebo group (Intention\u2010to\u2010treat analysis, <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a0.001, absolute difference\u00a0=\u00a00.7, 95%IC 0.43 0.96). Oropharyngeal symptoms were equally frequent in both groups. No dysphagia or other signs of eosinophilic oesophagitis occurred. Digestive adverse events (AE) were more frequent in the treated group (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.02), but mild and without compliance issues. Only one severe advent event led to withdrawal in a patient who ingested twice the investigated treatment. Peanut\u2010specific humoral immune responses were modulated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The GIDOIT protocol demonstrated clinical and immunological efficacy and had an acceptable level of safety with weak oropharyngeal symptoms, no dysphagia, mild digestive events and few severe systemic AE.<\/jats:p><\/jats:sec>","DOI":"10.1111\/cea.13148","type":"journal-article","created":{"date-parts":[[2018,4,17]],"date-time":"2018-04-17T18:03:48Z","timestamp":1523988228000},"page":"862-874","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Peanut gastrointestinal delivery oral immunotherapy in adolescents: Results of the build\u2010up phase of a randomized, double\u2010blind, placebo\u2010controlled trial (PITA 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Clermont\u2010Ferrand Clermont\u2010Ferrand France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Bernard","sequence":"additional","affiliation":[{"name":"D\u00e9partement de Pharmacie CHU Clermont\u2010Ferrand Clermont\u2010Ferrand France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Gourdon\u2010Dubois","sequence":"additional","affiliation":[{"name":"Unit\u00e9 d'allergologie de l'enfant CHU Estaing Pole p\u00e9diatrique CHU Clermont\u2010Ferrand Clermont\u2010Ferrand France"},{"name":"INSERM CIC 1405 CHU Clermont\u2010Ferrand Clermont\u2010Ferrand France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.\u2010O.","family":"Rouzaire","sequence":"additional","affiliation":[{"name":"Service d'Immunologie CHU Gabriel\u2010Montpied CHU Clermont\u2010Ferrand Clermont\u2010Ferrand France"},{"name":"UFR Pharmacie, ERTICa Universit\u00e9 Clermont Auvergne Clermont\u2010Ferrand 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