The Effect of Non-pooled Multidonor Faecal Microbiota Transplantation for Inducing Clinical Remission in Patients with Chronic Pouchitis: Results from a Multicentre, Randomised, Double-blinded, Placebo-controlled Trial [MicroPouch].

Sabrina Just Kousgaard, Frederik Cold, Sofie Ingdam Halkjær, Andreas Munk Petersen, Jens Kjeldsen, Jane Møller Hansen, Sebastian Mølvang Dall, Mads Albertsen, Hans Linde Nielsen, Karina Frahm Kirk, Kirsten Duch, Mads Sønderkær, Ole Thorlacius-Ussing
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Abstract

Background and aims: To investigate if treatment with non-pooled, multidonor faecal microbiota transplantation [FMT] for 4 weeks was superior to placebo to induce clinical remission in patients with chronic pouchitis.

Methods: The study was a randomised, double-blinded, placebo-controlled study with a 4-week intervention period and 12-month follow-up. Eligible patients with chronic pouchitis were recruited from five Danish hospitals. Participants were randomised to non-pooled, multidonor FMT derived from four faecal donors, or placebo. Treatment was delivered daily by enema for 2 weeks, followed by every second day for 2 weeks. Disease severity was accessed at inclusion and 30-day follow-up, using the Pouchitis Disease Activity Index [PDAI]; PDAI <7 was considered equivalent to clinical remission. Faecal samples from participants and donors were analysed by shotgun metagenomic sequencing.

Results: Inclusion was stopped after inclusion of 30 participants who were randomised 1:1 for treatment with FMT or placebo. There was no difference in participants achieving clinical remission between the two groups at 30-day follow-up, relative risk 1.0 (95% CI [0.55; 1.81]). Treatment with FMT resulted in a clinically relevant increase in adverse events compared with placebo, incidence rate ratio 1.67 (95% CI [1.10; 2.52]); no serious adverse events within either group. Faecal microbiota transplantation statistically significantly increased the similarity of participant faecal microbiome to the faecal donor microbiome at 30-day follow-up [p = 0.01], which was not seen after placebo.

Conclusions: Non-pooled, multidonor FMT was comparable to placebo in inducing clinical remission in patients with chronic pouchitis, but showed a clinically relevant increase in adverse events compared with placebo. ClincialTrials.gov number, NCT04100291.

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非集合多供体粪便微生物群移植对诱导慢性肠袋炎患者临床缓解的效果:多中心随机双盲安慰剂对照试验(MicroPouch)的结果。
背景与目的研究非集合多供体粪便微生物群移植(FMT)治疗四周是否优于安慰剂,以诱导慢性胃袋炎患者的临床缓解:该研究是一项随机双盲安慰剂对照研究,干预期为4周,随访期为12个月。符合条件的慢性胃袋炎患者来自丹麦的五家医院。参与者被随机分配到来自四名粪便捐献者的非集合多捐献者 FMT 或安慰剂中。每天灌肠治疗两周,然后每隔一天灌肠治疗两周。在纳入治疗和 30 天随访时,使用肛门袋炎疾病活动指数 (PDAI) 评估疾病严重程度;PDAI 结果:30名参与者按1:1的比例随机接受FMT或安慰剂治疗,之后停止纳入。在30天的随访中,两组获得临床缓解的参与者没有差异,相对风险为1.0(95%CI(0.55;1.81))。与安慰剂相比,粪便微生物群移植治疗会导致不良事件的临床相关性增加,发生率比为1.67(95%CI(1.10;2.52));两组中均未出现严重不良事件。粪便微生物群移植在统计学上显著提高了随访30天时参与者粪便微生物群与粪便供体微生物群的相似度(P=0.01),而安慰剂治疗后则没有这种效果:结论:在诱导慢性胃袋炎症患者临床缓解方面,非集合多供体 FMT 的效果与安慰剂相当,但与安慰剂相比,不良事件的增加具有临床相关性。
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