{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T08:33:35Z","timestamp":1787646815312,"version":"build-2736575974"},"reference-count":45,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2023,3,7]],"date-time":"2023-03-07T00:00:00Z","timestamp":1678147200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Experimental Allergy"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Mixed and non\u2010IgE\u2010mediated food allergy is a subset of immune\u2010mediated adverse food reactions that can impose a major burden on the quality of life of affected patients and their families. Clinical trials to study these diseases are reliant upon consistent and valid outcome measures that are relevant to both patients and clinicians, but the degree to which such stringent outcome reporting takes place is poorly studied.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>As part of the Core Outcome Measures for Food Allergy (COMFA) project, we identified outcomes reported in randomized clinical trials (RCT) of treatments for mixed or non\u2010IgE\u2010mediated food allergy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>In this systematic review, we searched the Ovid, MEDLINE and Embase databases for RCTs in children or adults investigating treatments for food protein\u2010induced enterocolitis syndrome, food protein\u2010induced allergic proctocolitis, food protein\u2010induced enteropathy and eosinophilic gastrointestinal disorders including eosinophilic esophagitis [EoE], eosinophilic gastritis and eosinophilic colitis published until 14 October 2022.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Twenty\u2010six eligible studies were identified, with 23 focused on EoE (88%). Most interventions were corticosteroids or monoclonal antibodies. All EoE studies assessed patient\u2010reported dysphagia, usually using a non\u2010validated questionnaire. Twenty\u2010two of 23 EoE studies used peak tissue eosinophil count as the primary outcome, usually using a non\u2010validated assessment method, and other immunological markers were only exploratory. Thirteen (57%) EoE studies reported endoscopic outcomes of which six used a validated scoring tool recently recommended as a core outcome for EoE trials. Funding source was not obviously associated with likelihood of an RCT reporting mechanistic versus patient\u2010reported outcomes. Only 3 (12%) RCTs concerned forms of food allergy other than EoE, and they reported on fecal immunological markers and patient\u2010reported outcomes.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Outcomes measured in clinical trials of EoE and non\u2010IgE\u2010mediated food allergy are heterogeneous and largely non\u2010validated. Core outcomes for EoE have been developed and need to be used in future trials. For other forms of mixed or non\u2010IgE\u2010mediated food allergies, core outcome development is needed to support the development of effective treatments.<\/jats:p><\/jats:sec><jats:sec><jats:title>Systematic review registration<\/jats:title><jats:p>OSF public registry DOI:<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/10.0.68.197\/OSF.IO\/AZX8S\">10.17605\/OSF.IO\/AZX8S<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1111\/cea.14304","type":"journal-article","created":{"date-parts":[[2023,3,7]],"date-time":"2023-03-07T12:17:18Z","timestamp":1678191438000},"page":"526-535","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Outcomes reported in randomized controlled trials for mixed and <scp>non\u2010IgE\u2010mediated<\/scp> food allergy: Systematic 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