Consecutive fecal microbiota transplantation for metabolic dysfunction-associated steatotic liver disease: a randomized controlled trial
Abstract
ABSTRACT The gut microbiota is increasingly considered a contributory factor in metabolic dysfunction-associated steatotic liver disease (MASLD). This double-blind RCT evaluated the effect of three consecutive fecal microbiota transplantations (FMT) on hepatic steatosis in MASLD. Twenty patients with MASLD were randomized (1:1) to receive allogeneic or autologous FMTs at weeks 0, 3, and 6, with follow-up through week 12. FMT material was derived from two donors. We assessed changes in hepatic steatosis (magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF)), glucose tolerance (oral glucose tolerance test), liver biochemistry, and gut microbiota composition/engraftment. Change in MRI-PDFF from baseline to week 12 was not significantly different between groups (p = 0.50). Liver biochemistry and glucose tolerance also showed no significant overall changes. Patients’ stool microbiota exhibited high baseline alpha diversity and similar composition across treatment groups, diverging by week 12 (p = 0.02). Two microbial taxa belonging to the families Gastranaerophilaceae and Rikenellaceae were associated with triglyceride levels after FMT. No further microbiota signatures were associated with FMT-treatment or response. Donor microbiota engraftment appeared donor-specific, but not treatment- or response-specific. In conclusion, FMT did not significantly affect hepatic steatosis, glucose tolerance, liver biochemistry, or gut microbiota signatures. Future studies…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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