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

被引:1
|
作者
Prosberg, Michelle, V [1 ,2 ]
Halkjaer, Sofie, I [1 ,2 ]
Lo, Bobby [1 ,2 ]
Bremerskov-Koser, Christina [1 ,2 ]
Ilvemark, Johan F. K. F. [3 ]
Seidelin, Jakob B. [3 ,4 ]
Kristiansen, Malene F. [5 ]
Kort, Anja [5 ]
Kallemose, Thomas [6 ]
Bager, Peter [7 ]
Bendtsen, Flemming [1 ,2 ,4 ]
Nordgaard-Lassen, Inge [1 ,2 ]
Kapel, Hanne S. [8 ]
Kringel, Helene [8 ]
Kapel, Christian M. O. [8 ,9 ]
Petersen, Andreas M. [1 ,2 ,4 ,10 ]
机构
[1] Copenhagen Univ Hosp Amager & Hvidovre, Med Div, Gastrounit, Hvidovre, Denmark
[2] Copenhagen Univ Hosp Amager & Hvidovre, Copenhagen IBD Ctr, Hvidovre, Denmark
[3] Copenhagen Univ Hosp Gentofte & Herlev, Dept Gastroenterol & Hepatol, Herlev, Denmark
[4] Univ Copenhagen, Dept Clin Med, Copenhagen, Denmark
[5] Univ Copenhagen, Bispebjerg Hosp, Digest Dis Ctr, Copenhagen, Denmark
[6] Copenhagen Univ Hosp Amager & Hvidovre, Dept Clin Res, Hvidovre, Denmark
[7] Statens Serum Inst, Div Infect Dis Preparedness, Copenhagen, Denmark
[8] ParaTech AS, Horsholm, Denmark
[9] Univ Copenhagen, Dept Plant & Environm Sci, Frederiksberg, Denmark
[10] Copenhagen Univ Hosp Amager & Hvidovre, Dept Clin Microbiol, Hvidovre, Denmark
来源
JOURNAL OF CROHNS & COLITIS | 2024年 / 18卷 / 11期
关键词
Ulcerative Colitis; randomised clinical trial; Trichuris suis ova; INFLAMMATORY-BOWEL-DISEASE; HELMINTH THERAPY; OVA; TOLERABILITY; GUIDELINES; PARASITES; SAFETY;
D O I
10.1093/ecco-jcc/jjae095
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
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.
引用
收藏
页码:1879 / 1893
页数:15
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