Selvig Daniel, Piceno Yvette, Terdiman Jonathan, Zydek Martin, Umetsu Sarah E, Balitzer Dana, Fadrosh Doug, Lynch Kole, Lamere Brandon, Leith Tom, Kassam Zain, Beck Kendall, Lewin Sara, Ma Averil, Somsouk Ma, Lynch Susan V, El-Nachef Najwa
Division of Gastroenterology, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.
Department of Pathology, University of California, San Francisco, San Francisco, CA, USA.
Dig Dis Sci. 2020 Apr;65(4):1099-1106. doi: 10.1007/s10620-019-05715-2. Epub 2019 Jul 13.
This pilot study assessed the efficacy, safety, and microbiome dynamics of fecal microbiota transplantation (FMT) for patients with chronic pouchitis.
A prospective open-label pilot study was performed at an academic center among pouchitis patients undergoing FMT. Patients received a minimum of a single FMT by pouchoscopy from healthy, screened donors. The primary outcome was clinical improvement in pouchitis assessed by patient survey at week 4. Secondary outcomes included decrease in total Pouchitis Disease Activity Index (PDAI) Score ≥ 3 at week 4, bowel movement frequency, ESR, CRP, fecal calprotectin, abdominal pain, and PDAI subscores including endoscopic and histologic changes. Stool samples were collected at baseline and 4 weeks post-FMT to assess bacterial microbiota using V4 16S rRNA sequencing.
Nineteen patients were enrolled; however, 1 patient was lost to follow-up. No patients had a major adverse event or escalation of therapy related to FMT. Total PDAI scores, endoscopic scores, and histologic scores did not decrease significantly post-FMT. However, there was a statistically significant improvement in bowel movement (BM) frequency (9.25-7.25 BM/day, p = 0.03) and trend for improvement in abdominal pain to improve post-FMT (p = 0.05). Bacterial microbiota profiling revealed no distinct community-level changes post-FMT, though a small number of specific bacterial taxa significantly differed in relative abundance.
A single FMT has a tolerable short-term safety profile and may be associated with a decrease in bowel movements in patients with chronic pouchitis; however, no robust endoscopic or histologic changes were observed.
本试点研究评估了粪便微生物群移植（FMT）对慢性袋炎患者的疗效、安全性和微生物群动态变化。
在一个学术中心对接受FMT的袋炎患者进行了一项前瞻性开放标签试点研究。患者通过袋镜检查至少接受一次来自健康、经过筛查的供体的FMT。主要结局是在第4周通过患者调查评估的袋炎临床改善情况。次要结局包括第4周时袋炎疾病活动指数（PDAI）总分降低≥3分、排便频率、红细胞沉降率（ESR）、C反应蛋白（CRP）、粪便钙卫蛋白、腹痛以及PDAI子评分，包括内镜和组织学变化。在基线和FMT后4周收集粪便样本，使用V4 16S rRNA测序评估细菌微生物群。
共纳入19例患者；然而，1例患者失访。没有患者发生与FMT相关的重大不良事件或治疗升级。FMT后PDAI总分、内镜评分和组织学评分均未显著降低。然而，排便（BM）频率有统计学显著改善（从9.25次/天降至7.25次/天，p = 0.03），并且FMT后腹痛有改善趋势（p = 0.05）。细菌微生物群分析显示FMT后没有明显的群落水平变化，尽管少数特定细菌类群的相对丰度有显著差异。
单次FMT具有可耐受的短期安全性，可能与慢性袋炎患者排便次数减少有关；然而，未观察到明显的内镜或组织学变化。
