INTRODUCTION Fecal microbiota transplantation (FMT) has shown promise at inducing remission in ulcerative colitis. This study is the first of its kind to evaluate the efficacy and safety of FMT at inducing remission in Crohn's disease (CD). METHODS This double-blind, placebo-controlled trial was conducted in 3 Canadian academic centers; randomized patients with mild-to-moderate CD received FMT or placebo. The first treatment was administered by colonoscopy followed by weekly oral capsules for 7 weeks. Primary end point was clinical and endoscopic remission at week 8. Secondary outcomes included clinical and endoscopic response, adverse events, and health-related quality of life using generic and disease-specific instruments. RESULTS From July 2017 to June 2021, 21 and 13 patients were randomized to FMT and placebo groups, respectively. The trial terminated early due to futility. At week 8, 0% (0/15) of patients in the FMT group versus 8.3% (1/11) in the placebo group reached the primary end point of combined clinical and endoscopic remission as per protocol analysis. There were no differences between the groups in clinical or endoscopic responses. One patient in each group had worsening of CD. Although both groups experienced statistically significant improvements in health-related quality of life, only the FMT group had a significant decrease in activity impairment. Although there were no significant changes in microbial diversity or composition, patients who achieved clinical response became more similar to their donors in stool microbial composition. DISCUSSION FMT was not effective at inducing clinical and endoscopic remission in CD using the FMT regimen in this study. Future studies may use other strategies to enhance treatment response, including longer intervention, antibiotic pretreatment, optimized donor-recipient pairing, and concomitant anti-inflammatory diet, and biologic or small molecule therapies.

中文翻译：

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一项使用粪便微生物群移植诱导轻度至中度克罗恩病患者缓解的多中心随机试验的初步结果。


引言 粪便微生物群移植 （FMT） 已显示出诱导溃疡性结肠炎缓解的前景。这项研究是同类研究中首次评估 FMT 诱导克罗恩病 （CD） 缓解的疗效和安全性。方法 这项双盲、安慰剂对照试验在 3 个加拿大学术中心进行;随机分配的轻中度 CD 患者接受 FMT 或安慰剂。第一次治疗通过结肠镜检查给药，然后每周口服胶囊，持续 7 周。主要终点是第 8 周的临床和内窥镜缓解。次要结局包括临床和内窥镜反应、不良事件以及使用通用和疾病特异性工具的健康相关生活质量。结果 2017年7月至 2021年6月，21 例和 13 例患者分别被随机分配到 FMT 组和安慰剂组。由于徒劳，试验提前终止。根据方案分析，在第 8 周时，FMT 组 0% （0/15） 的患者与安慰剂组 8.3% （1/11） 的患者达到临床和内窥镜联合缓解的主要终点。两组之间的临床或内窥镜反应没有差异。每组 1 例患者 CD 恶化。尽管两组在健康相关生活质量方面均有统计学意义改善，但只有 FMT 组的活动障碍显著减少。尽管微生物多样性或组成没有显着变化，但获得临床反应的患者在粪便微生物组成方面与其供体更加相似。讨论 在本研究中，FMT 方案对诱导 CD 的临床和内窥镜缓解无效。 未来的研究可能会使用其他策略来增强治疗反应，包括更长时间的干预、抗生素预处理、优化的供体-受体配对以及伴随的抗炎饮食，以及生物或小分子疗法。