Fecal Microbiota Transplant as Treatment of Hepatic Encephalopathy (NCT03420482)
๐ฉบ 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: Review the eligibility criteria below.
Location: Massachusetts General Hospital โ Boston, Massachusetts
Age range: 18 Years to 75 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Massachusetts General Hospital โ Boston, Massachusetts
๐ฐ 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 ยง 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 โ Homewood, Alabama
- Study to Assess Rifaximin Soluble Solid Dispersion (SSD) for the Delay of Encephalopathy Decompensation in Cirrhosis โ Dothan, Alabama
- Revealing Engagement Patterns Among Hepatic Encephalopathy Patients โ San Francisco, California
- Endoscopic Shunts Embolization for Refractory Hepatic Encephalopathy โ Newark, New Jersey
- Microbiota trAnSplant ThERaPy In hEpatiC Encephalopathy (MASTERPIECE) โ West Haven, Connecticut
Explore by condition: All Hepatic Encephalopathy clinical trials
๐ก 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.