Goloshchapov O V, Chukhlovin A B, Bakin E A, Stanevich O V, Klementeva R V, Shcherbakov A A, Shvetsov A N, Suvorova M A, Bondarenko S N, Kucher M A, Kulagin A D, Zubarovskaya L S, Moiseev I S
Gorbacheva Memorial Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov First Saint Petersburg State Medical University.
The Explana Research Laboratory.
Ter Arkh. 2020 Sep 1;92(7):43-54. doi: 10.26442/00403660.2020.07.000773.
Was to evaluate clinical efficacy, adverse events and changes in the gut microbiome after fecal microbiota transplantation (FMT) in patients with gastrointestinal (GI) form of graft-versus-host disease (GVHD).
The prospective single-center study in R.M. Gorbacheva institute included 27 patients with GI GVHD after allogeneic stem cell transplantation. 19 patients received FMT, 8 patients received placebo. Clinical scales for GI autoimmune diseases were used to evaluate response. Microbiome alterations were assessed with multiplex PCR.
After FMT higher overall bacterial mass (р=0.00088), higher bacterial numbers ofBifidobacteriumspp. (р=0.021),Escherichia coli(р=0.049) andBacteroides fragilisgr. (р=0.000043) compared to placebo group. Also higher bacterial mass was observed in patients with clinical response (р=0.0057). The bacterial mass after procedure in non-responders was compared to the placebo group (р=0.31). Partial response of GVHD was achieved faster in the FMT group compared to placebo (median 4 days vs 48 days,p=0.014). Complete response was observed in 8 (42%), 14 (74%) and 16 (84%) at 30, 60 and 90 days respectively, while in the placebo group only 0%, 1 (13%) and 4 (50%) achieved complete response at the same time points. The incidence and severity of adverse events was comparable between FMT and the placebo group.
FMT in patients with refractory GI GVHD was associated with favorable clinical outcomes and recovery in certain marker bacterial populations. Multiplex PCR can be used to assess an engraftment of a donor microbiota. FMT in GI GVHD was not associated with life-threatening adverse events, but further studies are required to validate clinical efficacy.
评估胃肠道（GI）型移植物抗宿主病（GVHD）患者粪便微生物群移植（FMT）后的临床疗效、不良事件及肠道微生物群变化。
在R.M.戈尔巴乔娃研究所进行的前瞻性单中心研究纳入了27例异基因干细胞移植后发生胃肠道GVHD的患者。19例患者接受FMT，8例患者接受安慰剂。使用胃肠道自身免疫性疾病临床量表评估反应。通过多重PCR评估微生物群改变。
与安慰剂组相比，FMT后总体细菌量更高（p = 0.00088），双歧杆菌属细菌数量更高（p = 0.021）、大肠杆菌（p = 0.049）和脆弱拟杆菌群（p = 0.000043）。临床有反应的患者中也观察到更高的细菌量（p = 0.0057）。无反应者术后的细菌量与安慰剂组比较（p = 0.31）。与安慰剂相比，FMT组GVHD的部分反应实现得更快（中位时间4天对48天，p = 0.014）。分别在30、60和90天时，8例（42%）、14例（74%）和16例（84%）观察到完全反应，而在安慰剂组，在相同时间点只有0%、1例（13%）和4例（50%）实现完全反应。FMT组和安慰剂组不良事件的发生率和严重程度相当。
难治性胃肠道GVHD患者的FMT与良好的临床结果及某些标志性细菌群体的恢复相关。多重PCR可用于评估供体微生物群的植入。胃肠道GVHD的FMT与危及生命的不良事件无关，但需要进一步研究来验证临床疗效。
