FMT safe, ‘could prevent’ recurrence of hepatic encephalopathy in patients with cirrhosis
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Key takeaways:
- Patients who received oral and enema placebo experienced the highest recurrence of hepatic encephalopathy.
- Recurrence was associated with dose number and male sex but not administration route or donor type.
Recurrence of hepatic encephalopathy was lower among patients with cirrhosis and hepatic encephalopathy who received oral capsule or enema fecal microbiota transplant vs. placebo, according to research from EASL Congress.
“Hepatic encephalopathy (HE) is a major medical and psychosocial burden and is one of the leading causes of readmissions in cirrhosis,” Jasmohan Bajaj, MD, professor of internal medicine at Virginia Commonwealth University, told Healio. “Despite lactulose and rifaximin, there is still a substantial number of patients whose HE recurs, which unfortunately is not prioritized for liver transplant.”
Bajaj continued: “Our prior smaller phase 1 studies of FMT improved outcomes either by the enema or capsule route but questions regarding dose, route and donor type for FMT in a larger population remain.”
In a double-blind, placebo-controlled trial, Bajaj and colleagues compared the effect of oral capsule and enema FMT on recurrence of HE among 60 patients with cirrhosis and HE who were on lactulose and rifaximin. Patients were randomly assigned to active oral and enema (group 1), active oral and placebo enema (group 2), oral placebo and active enema (group 3) or oral and enema placebo (group 4) at baseline with a third oral dose at day 30. All FMT products originated from two donors.
The primary outcomes were safety and HE recurrence, defined as at least grade 2 on West-Haven criteria, while secondary outcomes included other adverse events; changes in infections, severity of cirrhosis and cognition; and patient-reported outcomes. Researchers followed all patients until death or 6 months.
According to study results, patients in group 4 experienced the highest HE recurrence (40%) compared with groups 1 (13%), 2 (13%) and 3 (0%), as well as liver-related hospitalizations (47% vs. 7%-20%). Researchers noted that two patients who died in group 1 had HE before death.
Although MELD, psychometric HE score and Stroop test results did not change, patient-reported Sickness Impact Profile (SIP) total/physical and psych results improved with FMT (P = 0.003).
Further, HE recurrence was associated with dose number (OR = 0.27; 95% CI, 0.1-0.79), male sex (OR = 0.16; 95% CI, 0.03-0.89) and physical SIP (OR = 1.05; 95% CI, 1.01-1.1).
“We found that FMT was safe and could prevent HE-related recurrences vs. placebo,” Bajaj told Healio. “The dose of FMT, route or donor type — one donor was omnivorous and one was vegan — did not matter.”
He continued: “We need to keep FMT in mind as an alternative, but larger studies are also needed.”
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Bajaj J, et al. Thematic trial: Phase 2 dose-ranging randomized clinical trial of capsular or enema fecal microbiota transplant to prevent hepatic encephalopathy in cirrhosis already on rifaximin and lactulose. Presented at: EASL Congress; June 05-08, 2024; Milan (hybrid).
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