Michelle V Prosberg, Sofie I Halkjær, Bobby Lo, Christina Bremerskov-Köser, Johan F K F Ilvemark, Jakob B Seidelin, Malene F Kristiansen, Anja Kort, Thomas Kallemose, Peter Bager, Flemming Bendtsen, Inge Nordgaard-Lassen, Hanne S Kapel, Helene Kringel, Christian M O Kapel, Andreas M Petersen
{"title":"Probiotic Treatment of Ulcerative Colitis with Trichuris Suis Ova: A Randomised, Double-blinded, Placebo-controlled Clinical Trial [the PROCTO Trial].","authors":"Michelle V Prosberg, Sofie I Halkjær, Bobby Lo, Christina Bremerskov-Köser, Johan F K F Ilvemark, Jakob B Seidelin, Malene F Kristiansen, Anja Kort, Thomas Kallemose, Peter Bager, Flemming Bendtsen, Inge Nordgaard-Lassen, Hanne S Kapel, Helene Kringel, Christian M O Kapel, Andreas M Petersen","doi":"10.1093/ecco-jcc/jjae095","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and aims: </strong>To demonstrate that administration of 7500 Trichuris suis ova [TSO] every second week over 24 weeks would reduce the intestinal inflammation in moderate ulcerative colitis.</p><p><strong>Methods: </strong>A single-centre, randomised, double-blinded, placebo-controlled, phase 2b clinical trial of 7500 Trichuris suis ova every 2 weeks for 24 weeks compared with placebo in moderate activity of ulcerative colitis [Mayo score 6-10] were performed. Primary outcome: clinical remission; secondary outcomes: clinical response at 24 weeks, complete corticosteroid-free clinical remission, endoscopic remission, symptomatic remission at 12 and 24 weeks, and partial Mayo score over time.</p><p><strong>Results: </strong>In all, 119 patients were randomised to Trichuris suis ova [n = 60] or placebo [n = 59]. At Week 24, clinical remission was achieved in 30% of Trichuris suis ova-treated vs 34% of placebo-treated (risk ratio [RR] = 0.89; 95% confidence interval [CI]: 0.52-1.50; p = 0.80, intention to treat). No difference was found in clinical response in any of the clinical response subgroups. However, in patients who did not need treatment with corticosteroids during the trial, a temporary effect of TSO was seen in the analysis of symptomatic remission at Week 12 [p = 0.01] and the partial Mayo score at Week 14 and Week 18 [p < 0.05 and p = 0.02].</p><p><strong>Conclusions: </strong>Compared with placebo, Trichuris suis ova administration was not superior in achieving clinical remission at Week 24 in ulcerative colitis or in achieving clinical Mayo score reduction, complete corticosteroid-free clinical remission, or endoscopic remission. However, Trichuris suis ova treatment induced symptomatic temporary remission at Week 12.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Crohn's & colitis","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/ecco-jcc/jjae095","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Background and aims: To demonstrate that administration of 7500 Trichuris suis ova [TSO] every second week over 24 weeks would reduce the intestinal inflammation in moderate ulcerative colitis.
Methods: A single-centre, randomised, double-blinded, placebo-controlled, phase 2b clinical trial of 7500 Trichuris suis ova every 2 weeks for 24 weeks compared with placebo in moderate activity of ulcerative colitis [Mayo score 6-10] were performed. Primary outcome: clinical remission; secondary outcomes: clinical response at 24 weeks, complete corticosteroid-free clinical remission, endoscopic remission, symptomatic remission at 12 and 24 weeks, and partial Mayo score over time.
Results: In all, 119 patients were randomised to Trichuris suis ova [n = 60] or placebo [n = 59]. At Week 24, clinical remission was achieved in 30% of Trichuris suis ova-treated vs 34% of placebo-treated (risk ratio [RR] = 0.89; 95% confidence interval [CI]: 0.52-1.50; p = 0.80, intention to treat). No difference was found in clinical response in any of the clinical response subgroups. However, in patients who did not need treatment with corticosteroids during the trial, a temporary effect of TSO was seen in the analysis of symptomatic remission at Week 12 [p = 0.01] and the partial Mayo score at Week 14 and Week 18 [p < 0.05 and p = 0.02].
Conclusions: Compared with placebo, Trichuris suis ova administration was not superior in achieving clinical remission at Week 24 in ulcerative colitis or in achieving clinical Mayo score reduction, complete corticosteroid-free clinical remission, or endoscopic remission. However, Trichuris suis ova treatment induced symptomatic temporary remission at Week 12.