No difference in ‘super donor’ vs autologous FMT for inducing remission in UC
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Among patients with ulcerative colitis, fecal microbiota transplantation with super donor stool was not superior to autologous stool in inducing remission, according to study results.
“Further role of FMT in [inflammatory bowel disease] needs to be studied,” Clara Caenepeel, MD, of the department of chronic disease and metabolism at KU Leuven in Belgium, said during a presentation at the Congress of the European Crohn’s and Colitis Organization. “Anaerobic FMT preparation and administration protocol is important for international standardization.”
In a double-blind, randomized trial, Caenepeel and colleagues assigned 66 patients with UC to receive either four anaerobic-prepared superdonor FMT (n = 30) or autologous FMT (n = 36). Patients were stratified by weight, concomitant steroid use and therapy refractoriness. Steroid-free clinical remission at week 8 served as the primary endpoint.
According to researchers, three patients from the superdonor FMT group (10%) and five patients in the autologous FMT group (13.9%) reached the primary endpoint; no patients on concomitant biologicals reached clinical remission. In the autologous FMT group, there were two serious adverse events, which included dysuria and worsening of ulcerative colitis.
“As the predefined minimum difference between both treatment arms was not attained, the study was stopped due to futility,” Caenepeel and colleagues noted.
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Caenepeel C, et al. Abstract OP03. Presented at: Congress of European Crohn’s and Colitis Organization; February 16-19, 2022 (virtual meeting).
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