The most relevant literature concerns Fecal Microbiota Transplantation (FMT) for complications of cirrhosis - especially hepatic encephalopathy - rather than FMT as a demonstrated treatment for reversing liver fibrosis.
Why Use Fecal Microbiota Transplantation (FMT) for Liver Fibrosis / Cirrhosis
Fecal microbiota transplantation (FMT) is being studied to alter the gut–liver axis. In chronic liver disease, gut microbial changes and impaired intestinal barriers may increase exposure to inflammatory microbial products and affect ammonia and metabolite pathways. Small trials in selected patients with cirrhosis and recurrent hepatic encephalopathy report improved cognition and possible reductions in episodes or hospitalizations. FMT was studied alongside standard care, such as lactulose and rifaximin - not in place of it (4, 5, 6)
Fecal Microbiota Transplantation (FMT) for Liver Fibrosis / Cirrhosis: Reviews And Meta-Analyses
Review by Tun et al. 2022 (8).
- Searched PubMed/MEDLINE through October 3, 2021, and included 8 studies - 3 randomized trials, 3 observational studies, and 2 case series. Across them, 127 patients with cirrhosis received FMT. The studies were too few and varied for a meta-analysis
- The included studies generally found improved cognitive-test performance or fewer HE recurrences after FMT; one study reported that cognitive improvement persisted at one-year follow-up
- Reported cure rates of recurrent/refractory C. difficile infection (rCDI) in the included studies were 75%–92%. Cirrhotic patients were more likely than non-cirrhotic patients to need multiple FMT doses; one study reported 2–3 doses in 22.6% versus 2.7%, respectively. More advanced cirrhosis and more severe CDI were associated with failure in some studies
- The review compiled 25 adverse events and 12 serious adverse events among the 127 patients. The authors described overall rates as low, but noted that some events - such as HE, infection, or death - could not be definitively attributed to or ruled out as related to FMT
- This is a small, heterogeneous evidence base - not proof of effectiveness or safety for every patient. The authors called for larger, better-designed studies
Fecal Microbiota Transplantation (FMT) for Liver Fibrosis / Cirrhosis: Randomized clinical trials
For this randomized clinical phase III trial NCT02862249, no published clinical results could be found as of January 2026 (1).
For this randomized clinical phase I/II trial NCT03014505, no published results could be found as of March 2026 (2, 3).
For the clinical phase I trial NCT03416751, no published clinical results could be found as of January 2026 (3).
For the clinical trial NCT04842539, no published clinical results could be found as of March 2026
For this randomized clinical phase II/III trial NCT04932577, no published results could be found as of April 2026
NCT03796598 - Fecal Microbiota Transplantation (FMT) & Liver Fibrosis / Cirrhosis
- Design: Small, double-blind, randomized phase II trial; 60 participants with cirrhosis, assigned to four regimens involving oral FMT capsules and/or an enema, or placebo; followed for six months.
- Safety: No adverse or serious adverse events were judged related to FMT. Overall serious adverse events, hospitalizations, and deaths were similar across groups.
- Hepatic encephalopathy recurrence: 10 of 60 participants (17%) had a recurrence. In a post hoc comparison, recurrence was 9.1% among participants receiving any FMT versus 40% with placebo only (OR 0.15, 95% CI 0.04–0.64). The trial did not establish which FMT regimen was best.
- Other outcomes: FMT did not significantly reduce all-cause hospitalization or death.
- Microbiome findings: Higher baseline Lachnospiraceae was associated with greater donor engraftment and less recurrence; these are associations, not proof of a mechanism.
- Interpretation: The recurrence and microbiome signals are promising, but exploratory. The study was small, the favorable comparison was post hoc, and secondary/post hoc analyses were not adjusted for multiple comparisons. Larger trials are needed to confirm the findings (7).
Fecal Microbiota Transplantation (FMT) for Liver Fibrosis / Cirrhosis: Conclusion
References
(1) Woodhouse et al. 2019 BMJ Open 9(2): e023518
(2) Zhao et al. 2023 J. Clin. Med. 12: 1683
(3) Boicean et al. 2023 Biomedicines 11(11): 2930
(4) Bloom P, Khanna S. Fecal microbiota transplantation in chronic liver disease: Current and future state of the art. Hepatol Commun. 2026 Mar 20;10(4):e0927
(5) Karna R, Babich M. Fecal microbiota transplant in liver diseases: Current evidence and future directions. Clin Liver Dis (Hoboken). 2024 Jun 5;23(1):e0154
(6) Ma L, Zhang MH, Xu YF, Hao YX, Niu XX, Li Y, Xing HC. Fecal microbiota transplantation: A promising treatment strategy for chronic liver disease. World J Gastroenterol. 2025 Jul 28;31(28):105089
(7) Bajaj et al. 2025 J Hepatol 83: 81-91
(8) Tun et al. 2022 Cureus 14(5): e25537
see also:
Fecal Microbiota Transplantation (FMT) & Alcoholic hepatitis
Fecal Microbiota Transplantation (FMT) & Hepatic encephalopathy (HE)
Fecal Microbiota Transplantation (FMT) & Non-Alcoholic Fatty Liver Disease (NAFLD) / Metabolic dysfunction-associated fatty liver disease (MAFLD)
Fecal Microbiota Transplantation (FMT) (procedure-based) & Preclinical/Clinical data
Liver Fibrosis / Cirrhosis & Drugs/Treatments
Microbiome-based therapeutics & Liver Fibrosis / Cirrhosis
