NCT03796598: Phase II FMT Trial Design and Treatment Arms
Phase II, double-blind, randomized, placebo-controlled trial; 60 participants, 15 per group, followed for 6 months.
Participants received oral capsules and/or an enema, with differing amounts of active Fecal Microbiota Transplantation (FMT) versus placebo. FMT came from one of two donors (1).
NCT03796598: FMT Safety and Serious Adverse Events in Cirrhosis
No adverse events or serious adverse events were judged related to FMT.
Overall serious adverse events, hospitalizations, and deaths were similar across groups (1).
NCT03796598: Hepatic Encephalopathy Recurrence After FMT
10 of 60 participants (17%) had a Hepatic encephalopathy (HE) recurrence. Recurrence differed across the four groups (p = 0.035).
In a post hoc comparison, recurrence was 40% with placebo only versus 9.1% among participants who received any FMT (OR 0.15, 95% CI 0.04–0.64).
Recurrence rates were similar among FMT recipients regardless of route, dose, or donor type. The trial did not establish which regimen is best (1).
NCT03796598: Microbiome Engraftment and FMT Response Signals
Higher baseline Lachnospiraceae was associated with greater donor engraftment and less recurrence; recurrence was also associated with lower donor engraftment.
These are associations, not proof of mechanism (1).
NCT03796598: Hospitalization, Mortality, and Quality of Life
FMT did not significantly reduce all-cause hospitalization or death.
Some quality-of-life measures improved in FMT groups; cognitive-test improvement was not significant in the mixed-effects analysis (1).
NCT03796598: Limitations and Need for Larger FMT Trials
This was a small phase II study, and the authors note it was not powered to establish Hepatic encephalopathy (HE)-recurrence effects within individual groups.
The favorable placebo-versus-FMT result was post hoc, and secondary/post hoc p values were not adjusted for multiple comparisons.
The findings are promising but need confirmation in larger trials (1).
