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. 2020 Aug 28;11:4333. doi: 10.1038/s41467-020-18127-y

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© The Author(s) 2020

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

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Fig. 1 — a Study design: after baseline clinical and microbiome assessments, patients were randomised to receive either donor faecal microbiota transplantation (D-FMT) or placebo FMT (P-FMT). Then, all patients were followed up to 8 weeks (follow-up visits at 1, 2, 4 and 8 weeks after treatments). b Summary of clinical results: D-FMT was significantly more effective than P-FMT in achieving the complete resolution of TKI-induced diarrhoea at 1 week (n = 10 vs n = 3, 100% vs 30%, p = 0.02), 2 weeks (n = 9 vs n = 0, 90% vs 0%, p = 0.0007), 4 weeks (primary outcome, n = 7 vs n = 0, 70% vs 0%, p = 0.003), but not at 8 weeks of follow-up (n = 3 vs n = 0, 30% vs 0%, p = 1), consistently with the single FMT infusion approach of the study. Nonetheless, the benefit of D-FMT over P-FMT in decreasing diarrhoea up to G1 grade or lower remained significant for the whole follow-up period, including 1 week (n = 10 vs n = 3, 100% vs 30%, p = 0.02), 2 weeks (n = 10 vs n = 2, 100% vs 20%, p = 0.005), 4 weeks (n = 10 vs n = 2, 100% vs 20%, p = 0.005) and 8 weeks (n = 8 vs n = 1, 80% vs 10%, p = 0.04) after the end of treatments. Differences in cure percentages were determined with Fisher’s exact test (with two-tailed p values). The Bonferroni adjustment was applied for multiple secondary outcomes.