Department of Gastroenterology, Dayanand Medical College & Hospital, Ludhiana, Punjab, India.
Department of Internal Medicine, Dayanand Medical College & Hospital, Ludhiana, India.
J Crohns Colitis. 2019 Sep 27;13(10):1311-1317. doi: 10.1093/ecco-jcc/jjz060.
To study the role of faecal microbiota transplantation [FMT] in maintenance of remission in ulcerative colitis [UC].
In this pilot study, patients with UC in clinical remission achieved after multi-session FMT were randomly allocated to either maintenance FMT or placebo colonoscopic infusion every 8 weeks, for 48 weeks. The standard of care [SOC] therapy was continued in all patients. The primary endpoint was maintenance of steroid-free clinical remission [Mayo score ≤2, all subscores ≤1] at Week 48. Secondary endpoints were achievement of endoscopic remission [endoscopic Mayo score 0] and histological remission [Nancy grade 0, 1] at Week 48.
In all, 61 patients in clinical remission were randomised to receive either FMT [n = 31] or placebo [n = 30]. The primary outcome was achieved in 27/31 [87.1%] patients allocated FMT versus 20/30 [66.7%] patients assigned placebo [p = 0.111]. Secondary endpoints of endoscopic remission (FMT: 18/31 [58.1%] versus placebo: 8/30 [26.7%], p = 0.026) and histological remission (FMT: 14/31 [45.2%] versus placebo: 5/30 [16.7%], p = 0. 033) were achieved in a significantly higher number of patients with FMT. Three patients receiving FMT [9.7%] and 8 patients on placebo [26.7%] relapsed. There were no serious adverse events necessitating discontinuation in patients on FMT; one patient who relapsed on placebo required colectomy.
Maintenance FMT in patients who are in clinical remission may help sustain clinical, endoscopic and histological remission in patients with UC.
研究粪便微生物群移植（FMT）在溃疡性结肠炎（UC）缓解维持中的作用。
在这项初步研究中，经多次 FMT 治疗后达到临床缓解的 UC 患者被随机分为维持 FMT 组或安慰剂结肠镜下输注组，每 8 周一次，共 48 周。所有患者均继续接受标准治疗[SOC]。主要终点是第 48 周时无类固醇的临床缓解（Mayo 评分≤2，所有亚评分≤1）。次要终点是第 48 周时达到内镜缓解（内镜 Mayo 评分 0）和组织学缓解（Nancy 分级 0、1）。
共有 61 例临床缓解的患者被随机分为接受 FMT [n=31]或安慰剂[n=30]。接受 FMT 的患者中有 27/31 [87.1%]达到主要终点，而接受安慰剂的患者中有 20/30 [66.7%]达到主要终点[P=0.111]。内镜缓解的次要终点（FMT：18/31 [58.1%]与安慰剂：8/30 [26.7%]，P=0.026）和组织学缓解的次要终点（FMT：14/31 [45.2%]与安慰剂：5/30 [16.7%]，P=0.033）在接受 FMT 的患者中更显著。3 名接受 FMT 的患者[9.7%]和 8 名接受安慰剂的患者[26.7%]复发。接受 FMT 的患者中没有因不良反应而需要停药的严重不良事件；1 名接受安慰剂后复发的患者需要结肠切除术。
在临床缓解的患者中进行维持性 FMT 可能有助于维持 UC 患者的临床、内镜和组织学缓解。
