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FMT capsules treat encephalopathy: ‘The way to the brain is through the gut’
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VIENNA — Fecal microbiota transplant, delivered via capsule, lessened hospitalizations for patients with hepatic encephalopathy while improving cognitive function, according to data presented during the International Liver Congress 2019.
“Many of these patients reach a dementia-like state that not only can cause a burden on themselves and the health care system, but a burden on their families from a medical, psychosocial and cognitive and socioeconomic standpoint,” Jasmohan S. Bajaj, MD, from the Virginia Commonwealth University, said during a press conference. “Patients with cirrhosis have an altered gut-liver-brain axis and this is something we need to fix before we even get a handle on disease.”
Bajaj said this study arose out of a previous study that showed improvement in HE after rectal delivery of FMT, but that the prior study had many caveats, including that patients did not like the enema delivery.
In this study, Bajaj aimed to determine safety and tolerability of oral delivery of FMT along with the effectiveness in preventing hospitalization, effect on microbiota, effect on intestinal barrier and effect on cognitive function. The researchers enrolled patients with cirrhosis and recurrent HE, defined as two or more episodes, currently controlled on lactulose and rifaximin. They excluded those who were unable to consent, those with a MELD higher than 17, those on absorbable antibiotics, those with dysphagia and those with contraindications to endoscopic procedures. Patients underwent a variety of samples and eligibility testing and were followed for 5 months after delivery.
“In essence, this was a safety and pathophysiological study of FMT vs. placebo in patients who are disadvantaged by our system ... and could be condemned to this cycle of admission and readmission and with every encephalopathy episode, a bit of their brain dies and never comes back. We need to break the cycle,” Bajaj said.
Part of the cycle break is finding a quality FMT. In this case, Bajaj said they were able to carry over the same donor from the rectal delivery study.
“There is a super donor — a super pooper — who has beneficial organisms. The organisms produce short chain fatty acids and other compounds that are missing in our patients with cirrhosis,” Bajaj said. “These are identical. They do not smell like poop. They do not taste like poop. They are not anything like poop. And the placebo was like placebo.”
Bajaj showed that the reduction in all-cause hospitalization in FMT without increase in infection was significant for total serious adverse events (P = .02) and any serious adverse events (P = .03).
“Long story short, there was no safety signal,” Bajaj said. But “there was a lot of improvement in the brain function.”
There was also improvement in lipopolysaccharide binding protein and microbiota makeup in those randomly assigned to receive FMT, Bajaj said.
“There was microbiota that was highly more beneficial microbiota similar to what was present in the donor,” Bajaj said. “Not only in the stool, but in the sigmoid colon ... as well as the duodenum where all the action happens.”
A phase 2 trial is in the planning stages to compare the oral and rectal delivery.
“It was safe. It showed a trend towards reduction in serious adverse events. There was clearly a trend toward brain dysfunction being improved as well as microbiota being improved,” he said. “In short, the way to the brain is through the gut and the more often we remember and practice a healthy diet — not only in cirrhosis — the better off we will be.” – by Katrina Altersitz
Reference:
Bajaj JS. PS-087. Presented at: International Liver Congress; April 10-14, 2019; Vienna, Austria.
Disclosures: Bajaj reports no relevant financial disclosures.