Probiotic Treatment of Ulcerative Colitis with Trichuris Suis Ova: A Randomised, Double-blinded, Placebo-controlled Clinical Trial [the PROCTO Trial].

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":" ","pages":"1879-1893"},"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.

益生菌治疗溃疡性结肠炎与猪毛滴虫卵:随机、双盲、安慰剂对照临床试验(PROCTO 试验)。
背景与目的证明在中度溃疡性结肠炎患者中,每两周服用 7500 颗鼠毛线虫卵 24 周可减少肠道炎症:方法:对中度活动性溃疡性结肠炎(梅奥评分 6-10 分)患者进行单中心、随机、双盲、安慰剂对照的 2b 期临床试验,与安慰剂相比,每两周服用 7500 颗鼠毛线虫卵 24 周。主要结果临床缓解。次要结果24周时的临床反应、完全无皮质类固醇临床缓解、内镜缓解、12周和24周时的症状缓解以及随时间变化的部分梅奥评分:119名患者随机接受了沙眼衣原体卵母细胞治疗(60人)和安慰剂治疗(59人)。在第24周时,30%的沙眼衣原体卵巢治疗者与34%的安慰剂治疗者实现了临床缓解(RR=0.89;CI:0.52-1.50;P=0.80,ITT)。在所有临床反应亚组中,临床反应均无差异。然而,在试验期间不需要使用皮质类固醇治疗的患者中,在对第12周症状缓解(p=0.01)以及第14周和第18周部分梅奥评分(pConclusions:与安慰剂相比,金黄色葡萄球菌卵巢囊在第24周实现溃疡性结肠炎临床缓解或实现临床梅奥评分降低、完全无皮质类固醇临床缓解或内镜缓解方面并无优势。不过,沙眼衣原体卵巢囊肿治疗在第 12 周时可诱导症状暂时缓解。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信