Digestive Disease Center, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.
Medical Oncology Unit, Comprehensive Cancer Center, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Università Cattolica del Sacro Cuore, Largo A. Gemelli 8, 00168, Rome, Italy.
Nat Commun. 2020 Aug 28;11(1):4333. doi: 10.1038/s41467-020-18127-y.
Diarrhoea is one of the most burdensome and common adverse events of chemotherapeutics, and has no standardised therapy to date. Increasing evidence suggests that the gut microbiome can influence the development of chemotherapy-induced diarrhoea. Here we report findings from a randomised clinical trial of faecal microbiota transplantation (FMT) to treat diarrhoea induced by tyrosine kinase inhibitors (TKI) in patients with metastatic renal cell carcinoma (ClinicalTrials.gov number: NCT04040712). The primary outcome is the resolution of diarrhoea four weeks after the end of treatments. Twenty patients are randomised to receive FMT from healthy donors or placebo FMT (vehicle only). Donor FMT is more effective than placebo FMT in treating TKI-induced diarrhoea, and a successful engraftment is observed in subjects receiving donor faeces. No serious adverse events are observed in both treatment arms. The trial meets pre-specified endpoints. Our findings suggest that the therapeutic manipulation of gut microbiota may become a promising treatment option to manage TKI-dependent diarrhoea.
腹泻是化疗最常见和最令人困扰的不良反应之一，但目前尚无标准化的治疗方法。越来越多的证据表明，肠道微生物组可能会影响化疗引起的腹泻的发展。在这里，我们报告了一项粪便微生物群移植（FMT）治疗转移性肾细胞癌（ClinicalTrials.gov 编号：NCT04040712）患者酪氨酸激酶抑制剂（TKI）诱导腹泻的随机临床试验结果。主要结局是治疗结束后四周腹泻的缓解情况。20 名患者被随机分配接受来自健康供体的 FMT 或安慰剂 FMT（仅载体）。供体 FMT 在治疗 TKI 诱导的腹泻方面比安慰剂 FMT 更有效，并且在接受供体粪便的受试者中观察到成功的定植。在两个治疗组中均未观察到严重不良事件。试验达到了预先指定的终点。我们的研究结果表明，对肠道微生物群的治疗性操纵可能成为管理 TKI 依赖性腹泻的一种有前途的治疗选择。
