BACKGROUND The role of the gut microbiota in Crohn's disease (CD) is established and fecal microbiota transplantation (FMT) is an attractive therapeutic strategy. No randomized controlled clinical trial results are available. We performed a randomized, single-blind, sham-controlled pilot trial of FMT in adults with colonic or ileo-colonic CD. METHOD Patients enrolled while in flare received oral corticosteroid. Once in clinical remission, patients were randomized to receive either FMT or sham transplantation during a colonoscopy. Corticosteroids were tapered and a second colonoscopy was performed at week 6. The primary endpoint was the implantation of the donor microbiota at week 6 (Sorensen index > 0.6). RESULTS Eight patients received FMT and nine sham transplantation. None of the patients reached the primary endpoint. The steroid-free clinical remission rate at 10 and 24 weeks was 44.4% (4/9) and 33.3% (3/9) in the sham transplantation group and 87.5% (7/8) and 50.0% (4/8; one patient loss of follow-up while in remission at week 12 and considered in flare at week 24) in the FMT group. Crohn's Disease Endoscopic Index of Severity decreased 6 weeks after FMT (p = 0.03) but not after sham transplantation (p = 0.8). Conversely, the CRP level increased 6 weeks after sham transplantation (p = 0.008) but not after FMT (p = 0.5). Absence of donor microbiota engraftment was associated with flare. No safety signal was identified. CONCLUSION The primary endpoint was not reached for any patient. In this pilot study, higher colonization by donor microbiota was associated with maintenance of remission. These results must be confirmed in larger studies (NCT02097797). Video abstract.

中文翻译：

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粪便菌群移植以维持克罗恩病缓解：一项先导性随机对照研究。

背景技术建立了肠道菌群在克罗恩病（CD）中的作用，粪便菌群移植（FMT）是一种有吸引力的治疗策略。没有随机对照临床试验结果。我们对患有结肠或回肠结肠CD的成人进行了FMT的随机，单盲，假对照对照试验研究。方法发作期间入组的患者接受口服皮质类固醇激素治疗。临床缓解后，患者将在结肠镜检查中随机接受FMT或假移植。皮质类固醇逐渐变细，在第6周进行第二次结肠镜检查。主要终点是在第6周植入供体菌群（Sorensen指数> 0.6）。结果8例患者接受了FMT和9例假手术。没有患者达到主要终点。假移植组在10和24周时无类固醇的临床缓解率分别为44.4％（4/9）和33.3％（3/9），分别为87.5％（7/8）和50.0％（4/8; 1个）在FMT组中，患者在缓解后第12周时失去随访，并在第24周时考虑爆发。克罗恩病内镜下严重程度指数在FMT后6周下降（p = 0.03），但在假移植后没有下降（p = 0.8）。相反，假手术移植后6周CRP水平升高（p = 0.008），而FMT后CRP水平没有升高（p = 0.5）。缺乏供体微生物群落植入与耀斑有关。未发现安全信号。结论没有达到任何患者的主要终点。在这项前期研究中，供体微生物群较高的定植与维持缓解有关。这些结果必须在更大的研究中得到证实（NCT02097797）。