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

Gianluca Ianiro, Ernesto Rossi, Andrew M. Thomas, Giovanni Schinzari, Luca Masucci, Gianluca Quaranta, Carlo Romano Settanni, Loris Riccardo Lopetuso, Federica Armanini, Aitor Blanco-Miguez, Francesco Asnicar, Clarissa Consolandi, Roberto Iacovelli, Maurizio Sanguinetti, Giampaolo Tortora, Antonio Gasbarrini, Nicola Segata and Giovanni Cammarota ()
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Gianluca Ianiro: Università Cattolica del Sacro Cuore
Ernesto Rossi: Università Cattolica del Sacro Cuore
Andrew M. Thomas: University of Trento
Giovanni Schinzari: Università Cattolica del Sacro Cuore
Luca Masucci: Università Cattolica del Sacro Cuore
Gianluca Quaranta: Università Cattolica del Sacro Cuore
Carlo Romano Settanni: Università Cattolica del Sacro Cuore
Loris Riccardo Lopetuso: Università Cattolica del Sacro Cuore
Federica Armanini: University of Trento
Aitor Blanco-Miguez: University of Trento
Francesco Asnicar: University of Trento
Clarissa Consolandi: Institute of Biomedical Technologies (IBT), Italian National Research Council (CNR)
Roberto Iacovelli: Università Cattolica del Sacro Cuore
Maurizio Sanguinetti: Università Cattolica del Sacro Cuore
Giampaolo Tortora: Università Cattolica del Sacro Cuore
Antonio Gasbarrini: Università Cattolica del Sacro Cuore
Nicola Segata: University of Trento
Giovanni Cammarota: Università Cattolica del Sacro Cuore

Nature Communications, 2020, vol. 11, issue 1, 1-6

Abstract: Abstract 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.

Date: 2020
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DOI: 10.1038/s41467-020-18127-y

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