Fecal Microbiota Transplant as Treatment of Hepatic Encephalopathy (NCT03420482)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (20 items).
Location: Massachusetts General Hospital — Boston, Massachusetts
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Current episode of overt HE as defined by West Haven Criteria Grades II to IV
- Expectation of liver transplantation within two months of the screening visit
- Current infection
- Variceal bleeding in the last 4 weeks
- Gut-absorbable or intravenous antibiotic therapy (including ciprofloxacin for SBP prophylaxis) in the last 3 months
- Alcohol or illicit drug intake within 3 months, by history and available serum testing; alcohol use will be characterized as \>1 alcoholic drink / month
- PSC as etiology of liver disease, as prior literature has suggested these individuals have a unique microbiome
- History of Roux-en-Y Gastric bypass
- On immunosuppressive medications
- Positive C. difficile test
- Scoring above a threshold cut-off on the Psychometric Hepatic Encephalopathy Score (PHES)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Massachusetts General Hospital — Boston, Massachusetts
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hepatic Encephalopathy
- Evaluation of Rifaximin SSD for Delaying Encephalopathy Decompensation in Patients With Cirrhosis — Homewood, Alabama
- Revealing Engagement Patterns Among Hepatic Encephalopathy Patients — San Francisco, California
- Affect of Melatonin on Sleep and Cognition in Cirrhosis — New York, New York
- Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis — Dothan, Alabama
- Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy — Cleveland, Ohio
- Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy — Rochester, Minnesota
Explore by condition: All Hepatic Encephalopathy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.