Consecutive fecal microbiota transplantation for metabolic dysfunction-associated steatotic liver disease: a randomized controlled trial (Aug 2025, n=20) "FMT did not significantly affect hepatic steatosis, glucose tolerance, liver biochemistry, or gut microbiota signatures" FMT

[Michael Harrop]

https://www.tandfonline.com/doi/full/10.1080/19490976.2025.2541035#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 should consider including patients with low microbiota diversity. Dutch Trial Register: NL-OMON48776; Central Committee on Research Involving Human Subjects: NL66705.058.18; Clinicaltrials.gov: NCT04465032.

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Donors:

two screened, healthy, lean donors (D01 and D08) with a BMI between 20 and 25 kg/m2 were used; five patients received FMT from D01 and five from D08.

FMT material was processed and provided by the Netherlands Donor Feces Bank (NDFB, Leiden, the Netherlands), which adheres to standardized procedures for the collection, screening, preparation and storage of donor fecal suspensions

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More evidence that the stool bank model and the standard donor criteria are non-viable.

each FMT treatment contained 60 g of feces, processed into a 198 ml feces suspension with 10% added glycerol, stored at −80°C until the day of FMT. FMT was administered directly into the duodenum via gastroduodenal endoscopy by an experienced gastroenterologist

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Zero results for "symptoms" or "adverse events". So it doesn't appear that they were tracked at all. It's incredible to so consistently observe this stunning level of incompetence from these people with our lives in their hands, and who virtually everyone automatically trusts and hardly ever criticizes.