Faecal microbiota transplantation for the treatment of diarrhoea induced by tyrosine-kinase inhibitors in patients with metastatic renal cell carcinoma: Nature Communications

G. Ianiro, E. Rossi, A.M. Thomas, G. Schinzari, L. Masucci, G. Quaranta, C.R. Settanni, L.R. Lopetuso, F. Armanini, A. Blanco-Miguez, F. Asnicar, C. Consolandi, R. Iacovelli, M. Sanguinetti, G. Tortora, A. Gasbarrini, N. Segata, G. Cammarota

Research output: Contribution to journalArticlepeer-review


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. © 2020, The Author(s).
Original languageEnglish
JournalNat. Commun.
Issue number1
Publication statusPublished - 2020


  • C reactive protein
  • fentanyl
  • immunoglobulin A
  • oxycodone
  • pazopanib
  • placebo
  • protein glutamine gamma glutamyltransferase antibody
  • protein tyrosine kinase inhibitor
  • sunitinib
  • enzyme inhibitor
  • tyrosine
  • carcinogen
  • cell
  • chemotherapy
  • diarrheal disease
  • digestive system
  • fecal coliform
  • induced response
  • inhibition
  • Akkermansia muciniphila
  • Alistipes
  • Alistipes putredinis
  • Article
  • Barnesiella intestinihominis
  • clinical article
  • clinical outcome
  • controlled study
  • diarrhea
  • double blind procedure
  • erythrocyte sedimentation rate
  • Escherichia coli
  • fecal microbiota transplantation
  • feces analysis
  • feces microflora
  • follow up
  • Gram negative anaerobic bacteria
  • human
  • intestine flora
  • kidney metastasis
  • Listeria monocytogenes
  • phylogenetic tree
  • randomized controlled trial
  • Roseburia
  • Roseburia inulinovorans
  • shotgun sequencing
  • Staphylococcus aureus
  • Vibrio cholerae
  • aged
  • complication
  • donor
  • drug therapy
  • dysbiosis
  • feces
  • female
  • kidney tumor
  • male
  • metabolism
  • middle aged
  • procedures
  • renal cell carcinoma
  • Aged
  • Carcinoma, Renal Cell
  • Diarrhea
  • Double-Blind Method
  • Drug Therapy
  • Dysbiosis
  • Enzyme Inhibitors
  • Fecal Microbiota Transplantation
  • Feces
  • Female
  • Gastrointestinal Microbiome
  • Humans
  • Kidney Neoplasms
  • Male
  • Middle Aged
  • Tissue Donors
  • Tyrosine


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