{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T22:24:28Z","timestamp":1789424668042,"version":"build-2803163510"},"reference-count":24,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2021,6,28]],"date-time":"2021-06-28T00:00:00Z","timestamp":1624838400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2021,8]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The healing of the mucosal lesion in patients with coeliac disease is slow.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To determine whether concurrent budesonide and gluten\u2010free diet hasten small bowel healing and symptomatic improvement in patients with newly diagnosed coeliac disease.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In a pilot, randomised, double\u2010blind trial, effects on Marsh grading and quantitative duodenal morphometry of 10\u00a0weeks' effervescent budesonide (initially 9\u00a0mg\/day) or placebo were assessed after 8 and 52\u00a0weeks. Multiple clinical measures and adverse events were assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Nineteen patients were randomised to budesonide and 18 to placebo. No differences (all <jats:italic>P<\/jats:italic>\u00a0&gt;\u00a00.32) were observed for the week\u20108 mucosal response (Marsh 0 or 1) (budesonide: 37% vs placebo: 28%), week\u20108 remission (Marsh 0) (32% vs 17%), week\u201052 response (63% vs 44%) and week\u201052 remission (42% vs 33%). Likewise, the improvement from baseline in villous\u2010height\u00a0:\u00a0crypt\u2010depth ratio was not different for the treatment groups. There were no statistically significant differences in clinical measures or adverse events between the treatment groups. No corticosteroid adverse effects were observed. In a post hoc analysis of all patients, Marsh 3C was present at the diagnostic biopsy in 1\/9 achieving mucosal remission at 8\u00a0weeks versus 18\/23 not (<jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.001) and mean villous\u2010height\u00a0:\u00a0crypt\u2010depth ratio was 1.06 (SD: 0.73) versus 0.46 (0.38) (<jats:italic>P<\/jats:italic>\u00a0=\u00a00.005).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In this pilot trial, induction therapy with budesonide had no significant effect on mucosal healing in patients with coeliac disease concurrently initiated on a gluten\u2010free diet. Mucosal remission at 8\u00a0weeks occurred in approximately one in four patients and was associated with less severe histological lesions at diagnosis.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.16446","type":"journal-article","created":{"date-parts":[[2021,6,28]],"date-time":"2021-06-28T18:22:21Z","timestamp":1624904541000},"page":"419-428","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Randomised clinical trial: adjunctive induction therapy with oral effervescent budesonide in newly diagnosed coeliac disease"],"prefix":"10.1111","volume":"54","author":[{"given":"Evan D.","family":"Newnham","sequence":"first","affiliation":[{"name":"Departments of Gastroenterology and Hepatology Eastern Health Melbourne Vic. Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7479-9669","authenticated-orcid":false,"given":"Daniel","family":"Clayton\u2010Chubb","sequence":"additional","affiliation":[{"name":"Departments of Gastroenterology and Hepatology Eastern Health Melbourne Vic. Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meena","family":"Nagarethinam","sequence":"additional","affiliation":[{"name":"Departments of Gastroenterology and Hepatology Eastern Health Melbourne Vic. Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Hosking","sequence":"additional","affiliation":[{"name":"Pathology Eastern Health Box Hill Vic. Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9108-1712","authenticated-orcid":false,"given":"Peter R.","family":"Gibson","sequence":"additional","affiliation":[{"name":"Departments of Gastroenterology and Hepatology Eastern Health Melbourne Vic. Australia"},{"name":"Department of Gastroenterology Alfred Health Melbourne Vic. 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