Fecal Microbiota Transplant for Hepatic Encephalopathy

Recruiting in Palo Alto (17 mi)

Overseen byRaymond Chung, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing whether giving healthy gut bacteria from a donor to patients with advanced liver disease can help improve their brain function. The treatment involves using stool from healthy people to replace unhealthy bacteria in the patients' guts. The goal is to see if this can help reduce confusion caused by hepatic encephalopathy.

Eligibility Criteria

This trial is for patients with advanced liver disease who've had at least one episode of hepatic encephalopathy (confusion due to liver problems) but are stable on current treatments. They must not have certain other health issues, recent drug or alcohol use, or be expecting a liver transplant soon.

Inclusion Criteria

You have to take lactulose and rifaximin regularly as prescribed by your doctor.

You have a history of a specific type of brain problem called hepatic encephalopathy, caused by certain medical conditions or events.

You have been diagnosed with cirrhosis based on tests done by a liver doctor.

Exclusion Criteria

Your blood tests show very high or very low levels of certain substances: creatinine, hemoglobin, sodium, calcium, or potassium.

You have tested positive for C. difficile.

You have had a previous case of spontaneous bacterial peritonitis.

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Participant Groups

The study tests if swallowing capsules containing healthy stool bacteria can improve brain function in liver disease patients compared to placebo capsules. It's a randomized controlled trial, meaning participants are randomly assigned to receive either the real treatment or a placebo.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Fecal Microbiota Transplant (FMT) oral capsulesExperimental Treatment1 Intervention

Subjects will receive 15 oral capsules of FMT on days 1, 2, 7, 14, and 21.

Group II: Placebo capsulesPlacebo Group1 Intervention

Subjects will receive placebo capsules on the same schedule as the experimental arm (days 1, 2, 7, 14, and 21).