Fecal Microbiota Transplantation (FMT) & Non-Alcoholic Fatty Liver Disease (NAFLD) / Metabolic dysfunction-associated fatty liver disease (MAFLD)

Fecal Microbiota Transplantation (FMT) is a promising strategy that can reverse the intestinal dysbiosis associated with Non-Alcoholic Fatty Liver Disease (NAFLD) / Metabolic dysfunction-associated fatty liver disease (MAFLD) (2). FMT is being actively explored as a gut–liver axis–targeted therapy in NAFLD, with early signals on microbiome, epigenetic and metabolic readouts, but clinical efficacy on hard liver endpoints remains preliminary and inconsistent. FMT application is potentially useful, but it lacks randomized controlled trials to support recommendations. At present it should be viewed as an experimental adjunct within trials, not a standard treatment option for NAFLD/MAFLD (3, 4, 5, 10)

NAFLD/MAFLD is strongly linked to gut dysbiosis, increased intestinal permeability, endotoxemia, altered bile acid pools and microbially derived metabolites (ethanol, SCFAs, choline metabolites), all feeding into steatosis, inflammation and fibrogenesis via the Gut Microbiota-Liver-Axis (GLA) (6, 7, 8).

Randomized clinical trials (RCTs)

There has been an increase in the number of clinical studies evaluating Fecal Microbiota Transplantation (FMT) in Non-Alcoholic Fatty Liver Disease (NAFLD) treatment, however, existing findings diverge on its effects. Three randomized controlled trials (RCTs) were conducted between 2013 and 2021, involving a total of 117 adult participants diagnosed with non-alcoholic fatty liver disease (NAFLD) (3).

NCT02496390
This randomized clinical phase I/II trial demonstrated that FMT did not improve insulin resistance, as measured by HOMA-IR or hepatic PDFF. Nonetheless, it indicated a potential to reduce small intestinal permeability in patients with NAFLD (1)

NCT03648086
No published results were found as of March 2026

NCT04465032
his randomized clinical phase IV treatment trial revealed that the fecal microbiota transplantation (FMT) did not have a significant impact on hepatic steatosis, glucose tolerance, liver biochemistry, or the signatures of gut microbiota. Future research should consider including patients who have low microbiota diversity (11).

NCT04594954
No published results were found as of March 2026

NCT05607745
No published results were found as of March 2026

XXX - Fecal Microbiota Transplantation (FMT) vs oral Probiotics & Non-Alcoholic Fatty Liver Disease (NAFLD) / Metabolic dysfunction-associated fatty liver disease (MAFLD)
This randomized clinical trial found that FMT significantly improved therapeutic outcomes for patients suffering from NAFLD. The study demonstrated that the clinical efficacy of FMT was more pronounced in patients with lean NAFLD compared to those who are obese (9).

Other trials

NCT06024681
No published results were found as of March 2026

References:

(1) Craven et al. 2020 The American Journal of Gastroenterology 115(7): 1055-1065
(2) Chen et al. 2020l
(3) Qiu et al. 2024 World J Gastroenterol 30(8): 833-842
(4) Abenavoli et al. 2024 Medicina 60: 563
(5) Malnick et al. 2021 Biology (Basel) 10(5): 447
(6) Jadhav et al. 2024 Egypt Liver Journal 14: 21
(7) Jayachandran & Qu 2023 Rev Endocr Metab Disord 24: 1189-1204
(8) Role of Gut-Liver Axis in Non-Alcoholic Fatty Liver Disease
(9) Xue et al. 2022 Front Cell Infect Microbiol 12: 759306
(10) Ortigão et al. 2020
(11) Groenewegen et al. 2025 Gut Microbes 17(1): 2541035

see also:
Fecal Microbiota Transplantation (FMT) & Adiposity / Obesity
Fecal Microbiota Transplantation (FMT) & Liver Fibrosis / Cirrhosis
Fecal Microbiota Transplantation (FMT) & Non-Alcoholic Steatohepatitis (NASH / MASH)
Non-Alcoholic Fatty Liver Disease (NAFLD) / Metabolic dysfunction-associated fatty liver disease (MAFLD) & Drugs/Treatments
PRIM-DJ2727 & Non-Alcoholic Fatty Liver Disease (NAFLD) / Metabolic dysfunction-associated fatty liver disease (MAFLD)