State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases and Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi Province, China.
Department of Medical Insurance, Xijing Hospital, Air Force Military Medical University, Xi'an, Shaanxi Province, China.
J Dig Dis. 2020 Nov;21(11):621-628. doi: 10.1111/1751-2980.12938. Epub 2020 Sep 29.
We aimed to evaluate the short-term efficacy and safety of fecal microbiota transplantation (FMT) by washed preparation for moderate to severely active UC.
An open-label prospective trial was conducted in an inflammatory bowel disease (IBD) tertiary referral center from April 2016 to March 2018. Patients with moderate to severely active UC were randomly assigned to undergo FMT thrice on day 1, 3 and 5 by nasojejunal tube (NJT) or transendoscopic enteral tubing (TET). The primary end-point was a clinical response at week 2 post-FMT. The secondary end-points were clinical and endoscopic remission at week 12 post-FMT, safety and disease progression.
Of the nine patients included, 77.8% (7/9) achieved a clinical response at week 2. And 55.6% (5/9) and 33.3% (3/9), respectively, achieved clinical remission and endoscopic remission at week 12. In two patients who had no response to FMT, one switched to anti-tumor necrosis factor-α therapy, and the other underwent a colectomy. FMT was delivered through NJT in 44.4% (4/9) of the patients, while TET was used in 55.6% (5/9). The clinical outcomes did not differ significantly based on the delivery route (P > 0.05). Adverse events, all mild and self-limiting, were observed in 33.3% (3/9) of the patients.
FMT by washed preparation appears to be a safe and effective adjunct therapy for moderate to severely active UC during a short-term follow-up. The efficacy did not differ significantly between the NJT or TET delivery routes. Further randomized controlled studies are needed to confirm these findings.
评估经冲洗制备的粪便微生物群移植（FMT）治疗中重度活动期溃疡性结肠炎（UC）的短期疗效和安全性。
一项开放标签前瞻性试验于 2016 年 4 月至 2018 年 3 月在炎症性肠病（IBD）三级转诊中心进行。将中重度活动期 UC 患者随机分为经鼻空肠管（NJT）或经内镜肠内管（TET）在第 1、3 和 5 天接受 3 次 FMT。主要终点为 FMT 后 2 周的临床反应。次要终点为 FMT 后 12 周的临床和内镜缓解、安全性和疾病进展。
9 例患者中，77.8%（7/9）在第 2 周达到临床反应。55.6%（5/9）和 33.3%（3/9）分别在第 12 周达到临床缓解和内镜缓解。2 例对 FMT 无反应的患者中，1 例转为抗肿瘤坏死因子-α治疗，另 1 例接受结肠切除术。44.4%（4/9）的患者通过 NJT 进行 FMT，55.6%（5/9）的患者通过 TET 进行 FMT。两种输送途径的临床结果无显著差异（P＞0.05）。33.3%（3/9）的患者出现轻微且自限性的不良事件。
在短期随访期间，经冲洗制备的 FMT 似乎是中重度活动期 UC 的一种安全有效的辅助治疗方法。NJT 或 TET 输送途径的疗效无显著差异。需要进一步的随机对照研究来证实这些发现。
