Microbiota Transplant Therapy for Hepatic Encephalopathy

(MASTERPIECE Trial)

Not yet recruiting at 2 trial locations
JS
BC
Overseen ByBrian C Davis, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: VA Office of Research and Development
Must be taking: Lactulose, Rifaximin
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to find out whether changing the microbes in the bowels of Veterans with cirrhosis and hepatic encephalopathy (a condition that affects the brain as a result of liver problems) using capsules made from microbes from healthy people can prevent future episodes of hepatic encephalopathy.

Who Is on the Research Team?

JS

Jasmohan S. Bajaj, MD MS

Principal Investigator

Richmond VA Medical Center, Richmond, VA

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with cirrhosis or signs of liver damage.
Able to give written, informed consent (mini-mental status exam (MMSE) >25 at the time of consenting)
I have had episodes of hepatic encephalopathy before.
See 2 more

Exclusion Criteria

I have a long-term digestive disease like Crohn's or ulcerative colitis.
MELD3.0 score >22
WBC count <1000
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive microbiota transplant therapy (MTT) or placebo capsules twice a day for 2 weeks

2 weeks
Daily administration

Follow-up

Participants are monitored monthly for recurrence of hepatic encephalopathy and other outcomes

6 months
Monthly visits

What Are the Treatments Tested in This Trial?

Interventions

  • Microbiota transplant therapy (MTT) capsules

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: MTTExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+