longterm safety and efficacy of fecal microbiota transplant in active ulcerative colitis introduction and objective the therapeutic role of fecal microbiota transplantation in ulcerative colitis varies across different reports this study aims to evaluate the longterm safety and efficacy of a strategy called stepup fecal microbiota transplantation for ulcerative colitismethods two clinical trials nct01790061 nct02560727 for moderatetosevere ulcerative colitis mayo score range 612 were performed from november 2012 to july 2017 both studies were pooled for analysis on the safety and efficacy of fecal microbiota transplantation in patients with ulcerative colitis over a 1year followup the stepup fecal microbiota transplantation strategy included step 1 single fecal microbiota transplantation step 2 two or more fecal microbiota transplantations and step 3 fecal microbiota transplantations followed by immunosuppressants longterm clinical efficacy and adverse events were assessed and multiple factors related to fecal microbiota transplantation were evaluatedresults of 134 eligible patients in this realword study 813 109134 were included for analysis the followup ranged from 1 to 5 years fecal microbiota transplantationrelated adverse events were observed in 174 43247 of fecal microbiota transplantation procedures including one serious adverse event myasthenia gravis and 56 nonserious adverse events multivariable logistic regression analysis showed that both the method of preparation of microbiota from stool using the automatic system and the delivery method of colonic transendoscopic enteral tubing were associated with a lower rate of fecal microbiota transplantationrelated adverse events p0023 p0017 respectively in total 743 81109 and 514 56109 of patients achieved clinical response at 1 month and 3 months after stepup fecal microbiota transplantation respectivelyconclusions fecal microbiota transplantation should be a safe and promising therapy for ulcerative colitis the improved fecal microbiota preparation and colonic transendoscopic enteral tubing might reduce the rate of adverse events in ulcerative colitistrial registration clinicaltrialsgov nct01790061 nct02560727