What side effects are associated with this type of intervention?

Fecal Microbiota Transplantation (FMT) is being studied as a treatment for hepatic encephalopathy, a condition often associated with advanced liver disease. Common side effects of FMT include gastrointestinal symptoms such as diarrhea, abdominal cramping, and bloating. There is also a risk of infection transmission, although this is minimized through rigorous donor screening. Other treatments for hepatic encephalopathy, such as lactulose and rifaximin, can cause side effects like diarrhea, flatulence, and abdominal pain. Overall, while FMT shows promise, it is essential to consider these potential side effects and discuss them with a healthcare provider.

What prior FDA approvals exist?

The FDA has not specifically approved Fecal Microbiota Transplantation (FMT) for the treatment of hepatic encephalopathy. However, FMT is being studied as a potential treatment to restore healthy gut bacteria in patients with this condition. Current FDA-approved treatments for hepatic encephalopathy primarily include lactulose and rifaximin, which work by reducing the production and absorption of ammonia in the gut, thereby alleviating symptoms. These treatments aim to manage the underlying cause of encephalopathy by targeting gut bacteria, similar to the proposed mechanism of FMT.

What other types of research exist?

Promising novel alternatives to Fecal Microbiota Transplantation for hepatic encephalopathy patients include the use of prebiotics and probiotics to modulate gut microbiota, synbiotics (a combination of prebiotics and probiotics), and targeted antibiotic therapies to reduce harmful bacteria. Additionally, dietary modifications and the use of specific strains of beneficial bacteria are being explored as potential treatments.

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Microbiota Transplant

Fecal Microbiota Transplant for Hepatic Encephalopathy

Phase 2

Waitlist Available

Led By Raymond T Chung, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before the first administration of fmt (day 0) and one week after the last administration of fmt (day 28)

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include digestive discomfort or infection since fecal microbiota transplant involves introducing new bacteria into the body. However, specific side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before the first administration of fmt (day 0) and one week after the last administration of fmt (day 28)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before the first administration of fmt (day 0) and one week after the last administration of fmt (day 28)

This trial's timeline: 3 weeks for screening, Varies for treatment, and before the first administration of fmt (day 0) and one week after the last administration of fmt (day 28) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Psychometric Hepatic Encephalopathy Score (PHES)

Secondary study objectives

36-Item Short Form Health Survey (SF-36)

Adverse events

Ammonia

+2 more

Trial Design

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).

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for hepatic encephalopathy include lactulose, rifaximin, and fecal microbiota transplantation (FMT). Lactulose works by reducing the absorption of ammonia in the gut, converting it into non-absorbable ammonium, which is then excreted. Rifaximin is an antibiotic that decreases the production of ammonia by gut bacteria. FMT aims to restore a healthy gut microbiome by transplanting stool from a healthy donor, which can reduce the production of neurotoxic substances like ammonia. These treatments are crucial as they target the underlying cause of encephalopathy—excess ammonia and other toxins in the bloodstream—thereby improving neurological function and reducing symptoms such as confusion and cognitive impairment.