METHODS: We performed a prospective, multi-center study, conducted among patients who received a single dose of FMT from one of four healthy donors. The primary endpoint was complete clearance of CPE carriage two weeks after FMT with a secondary endpoint at three months. Shotgun metagenomic sequencing was performed to assess gut microbiota composition of donors and recipients before and after FMT.
RESULTS: Twenty CPE-colonized patients were included in the study, where post-FMT 20% (n = 4/20) of patients met the primary endpoint and 40% (n = 8/20) of patients met the secondary endpoint. Kaplan-Meier curves between patients with FMT intervention and the control group (n = 82) revealed a similar rate of decolonization between groups. Microbiota composition analyses revealed that response to FMT was not donor-dependent. Responders had a significantly lower relative abundance of CPE species pre-FMT than non-responders, and 14 days post-FMT responders had significantly higher bacterial species richness and alpha diversity compared to non-responders (p < 0.05). Responder fecal samples were also enriched in specific species, with significantly higher relative abundances of Faecalibacterium prausnitzii, Parabacteroides distasonis, Collinsella aerofaciens, Alistipes finegoldii and Blautia_A sp900066335 (q<0.01) compared to non-responders.
CONCLUSIONS: FMT administration using the proposed regimen did not achieve statistical significance for complete CPE decolonization but was correlated with the relative abundance of specific bacterial taxa, including CPE species.
方法:我们进行了前瞻性,多中心研究,在接受来自四个健康供体之一的单剂量FMT的患者中进行。主要终点是FMT后两周CPE携带的完全清除,次要终点是三个月。进行鸟枪宏基因组测序以评估FMT之前和之后的供体和受体的肠道微生物群组成。
结果:20名CPE定植患者被纳入研究,其中FMT后20%(n=4/20)的患者达到主要终点,40%(n=8/20)的患者达到次要终点.接受FMT干预的患者与对照组(n=82)之间的Kaplan-Meier曲线显示两组之间的脱色率相似。微生物组成分析表明,对FMT的反应不是供体依赖性的。应答者FMT前的CPE物种相对丰度明显低于非应答者,FMT后14天,与非反应者相比,FMT反应者具有显着更高的细菌物种丰富度和α多样性(p<0.05)。响应者的粪便样本也富含特定物种,普氏粪杆菌的相对丰度明显较高,双分支杆菌,科林塞拉气溶胶,与无反应者相比,费利氏和Blautia_Asp900066335(q<0.01)。
结论:使用拟议方案的FMT给药对于完全的CPE脱色没有达到统计学意义,但与特定细菌分类群的相对丰度相关,包括CPE物种。