Centre for Nutrition and Gastrointestinal Disease, Adelaide Medical School, University of Adelaide and South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
Inflammatory Bowel Disease Service, Department of Gastroenterology and Hepatology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.
JAMA. 2019 Jan 15;321(2):156-164. doi: 10.1001/jama.2018.20046.
High-intensity, aerobically prepared fecal microbiota transplantation (FMT) has demonstrated efficacy in treating active ulcerative colitis (UC). FMT protocols involving anaerobic stool processing methods may enhance microbial viability and allow efficacy with a lower treatment intensity.
To assess the efficacy of a short duration of FMT therapy to induce remission in UC using anaerobically prepared stool.
DESIGN, SETTING, AND PARTICIPANTS: A total of 73 adults with mild to moderately active UC were enrolled in a multicenter, randomized, double-blind clinical trial in 3 Australian tertiary referral centers between June 2013 and June 2016, with 12-month follow-up until June 2017.
Patients were randomized to receive either anaerobically prepared pooled donor FMT (n = 38) or autologous FMT (n = 35) via colonoscopy followed by 2 enemas over 7 days. Open-label therapy was offered to autologous FMT participants at 8 weeks and they were followed up for 12 months.
The primary outcome was steroid-free remission of UC, defined as a total Mayo score of ≤2 with an endoscopic Mayo score of 1 or less at week 8. Total Mayo score ranges from 0 to 12 (0 = no disease and 12 = most severe disease). Steroid-free remission of UC was reassessed at 12 months. Secondary clinical outcomes included adverse events.
Among 73 patients who were randomized (mean age, 39 years; women, 33 [45%]), 69 (95%) completed the trial. The primary outcome was achieved in 12 of the 38 participants (32%) receiving pooled donor FMT compared with 3 of the 35 (9%) receiving autologous FMT (difference, 23% [95% CI, 4%-42%]; odds ratio, 5.0 [95% CI, 1.2-20.1]; P = .03). Five of the 12 participants (42%) who achieved the primary end point at week 8 following donor FMT maintained remission at 12 months. There were 3 serious adverse events in the donor FMT group and 2 in the autologous FMT group.
In this preliminary study of adults with mild to moderate UC, 1-week treatment with anaerobically prepared donor FMT compared with autologous FMT resulted in a higher likelihood of remission at 8 weeks. Further research is needed to assess longer-term maintenance of remission and safety.
anzctr.org.au Identifier: ACTRN12613000236796.
高强度、需氧制备的粪便微生物群移植（FMT）已被证明对治疗活动性溃疡性结肠炎（UC）有效。涉及厌氧粪便处理方法的 FMT 方案可能会提高微生物的生存能力，并允许以较低的治疗强度实现疗效。
评估使用厌氧制备的粪便进行短期 FMT 治疗以诱导 UC 缓解的疗效。
设计、地点和参与者：2013 年 6 月至 2016 年 6 月期间，在澳大利亚 3 个三级转诊中心共招募了 73 名轻度至中度活动期 UC 成年患者，进行了一项多中心、随机、双盲临床试验，随访 12 个月，直至 2017 年 6 月。
患者被随机分为接受厌氧制备的 pooled donor FMT（n=38）或自体 FMT（n=35），通过结肠镜检查，然后在 7 天内进行 2 次灌肠。自体 FMT 参与者在 8 周时接受开放标签治疗，并随访 12 个月。
主要结局是 UC 的无类固醇缓解，定义为第 8 周时总 Mayo 评分≤2，内镜 Mayo 评分≤1。总 Mayo 评分范围为 0 至 12（0=无疾病，12=最严重疾病）。在 12 个月时重新评估 UC 的无类固醇缓解。次要临床结局包括不良事件。
在 73 名随机患者（平均年龄 39 岁；女性 33 名[45%]）中，69 名（95%）完成了试验。在接受 pooled donor FMT 的 38 名患者中，有 12 名（32%）达到了主要结局，而在接受自体 FMT 的 35 名患者中，只有 3 名（9%）达到了主要结局（差异，23%[95%CI，4%-42%]；比值比，5.0[95%CI，1.2-20.1]；P=0.03）。在接受 donor FMT 的 12 名达到主要终点的患者中，有 5 名（42%）在第 8 周时维持缓解至 12 个月。在 donor FMT 组中有 3 例严重不良事件，自体 FMT 组中有 2 例。
在这项对轻度至中度 UC 成人患者的初步研究中，与自体 FMT 相比，1 周的厌氧制备 donor FMT 治疗在第 8 周时更有可能缓解。需要进一步研究来评估长期缓解和安全性。
anzctr.org.au Identifier: ACTRN12613000236796.
