NCT03091010 - Fecal Microbiota Transplantation (FMT) vs Prednisolone & Alcoholic hepatitis

Background:

Severe Alcoholic Hepatitis has a high 90-day mortality rate. Prednisolone therapy offers modest survival benefits. It is effective at 28 days, but not at 90 days. Fecal microbial transplantation (FMT) shows promise for these patients (1)

Study overview:

It is a randomized open-label clinical treatment trial studying Fecal Microbiota Transplantation (FMT) or prednisolone in 112 eligible patients with severe alcoholic hepatitis (1)

Primary outcome measures:

Proportion of participants with Overall Survival at 3 months

Results:

In the intention-to-treat analysis, 90-day survival was 56.6% (34/60) for prednisolone and 75% (45/60) for FMT (p = 0.044, FMT HR = 0.528, 95%CI 0.279-0.998). The secondary outcome was 28-day survival: 78.33% (47/60) for prednisolone and 88.33% (53/60) for FMT (p = 0.243, FMT HR = 0.535, 95%CI 0.213-1.34) (1)

Conclusion:

Fecal Microbiota Transplantation (FMT) is safe. It improves 90-day survival, reduces infections, and modulates microbial communities favorably. It can be an alternative to prednisolone therapy (1)

References:

(1) Pande et al. 2023 Hepatol Int 17: 249-261