Fecal Microbiota Transplant as Treatment of Hepatic Encephalopathy
Status:
Active, not recruiting
Trial end date:
2022-01-31
Target enrollment:
Participant gender:
Summary
A common complication of advanced liver disease is a condition called hepatic encephalopathy,
which leads to confusion. The current treatment options cause side effects, are costly, and
do not always work. An abnormal population of bacteria in the intestines may be causing this
condition, and transplanting bacteria from the colon of a healthy person may treat it. In
this research study, the investigators will first find two healthy stool donors whose stool
donation improves the gut bacteria of patients with advanced liver disease and helps them
think more clearly. Then, in a randomized controlled trial, the investigators will compare
the ability of stool donation from these two best donors versus a placebo to improve the
neurological function of patients with advanced liver disease. If the investigators find the
expected results, there will be a new effective therapy for patients with advanced liver
disease and the very troublesome complication of hepatic encephalopathy.
Phase:
Phase 2
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborator:
Center for Microbiome Informatics and Therapeutics