Fecal Microbiota Transplant for Hepatic Encephalopathy

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must be taking: Lactulose, Rifaximin

Must not be taking: Immunosuppressives, Sedatives

Disqualifiers: Current infection, Alcohol use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 3 weeks

30 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be compliant with lactulose and rifaximin treatment. If you are on unstable doses of opiates, benzodiazepines, or other sedating medications, you may not be eligible.

Is fecal microbiota transplant (FMT) safe for humans?

Current evidence suggests that fecal microbiota transplant (FMT) is generally safe for humans, with some studies reporting minor and serious adverse events. However, more large-scale studies are needed to fully understand its safety profile. ^{1 2 3 4 5}

How does the treatment Fecal Microbiota Transplant (FMT) oral capsules differ from other treatments for hepatic encephalopathy?

FMT oral capsules are unique because they involve introducing healthy donor bacteria into the gut to improve brain function in hepatic encephalopathy, unlike traditional treatments that focus on reducing ammonia levels. This treatment is administered orally in capsule form, which is different from other methods like enemas or colonoscopy. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment Fecal Microbiota Transplant (FMT) oral capsules for hepatic encephalopathy?

Research shows that Fecal Microbiota Transplant (FMT) can improve cognitive function in patients with hepatic encephalopathy (HE), as seen in improved psychometric scores and reduced ammonia levels. FMT has been effective in other conditions like recurrent C. difficile infection, suggesting its potential in altering gut bacteria to benefit HE patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Raymond Chung, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Study

10-patient open-label pilot study to identify efficacious stool donors

Not specified

Treatment

Participants receive 5 doses of oral FMT capsules or placebo over 21 days

3 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fecal Microbiota Transplant (FMT) oral capsules
• Placebo oral capsule

Trial Overview 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.

How Is the Trial Designed?

Group I: Fecal Microbiota Transplant (FMT) oral capsules Experimental Treatment 1 Intervention

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

Group II: Placebo capsules Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Center for Microbiome Informatics and Therapeutics

Collaborator

Trials

1

Recruited

30+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplant improves cognition in hepatic encephalopathy and its effect varies by donor and recipient. [2023]

2. Belgium pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in hepatic encephalopathy : a review of the current evidence and future perspectives. [2021]

3. India pubmed.ncbi.nlm.nih.gov

Preliminary experience with single fecal microbiota transplant for treatment of recurrent overt hepatic encephalopathy-A case series. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Fecal microbiota transplantation in hepatic encephalopathy: a systematic review. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Gut Microbiota Modulation and Fecal Transplantation: An Overview on Innovative Strategies for Hepatic Encephalopathy Treatment. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Fecal Microbial Transplant Capsules Are Safe in Hepatic Encephalopathy: A Phase 1, Randomized, Placebo-Controlled Trial. [2021]