Microbiota trAnSplant ThERaPy In hEpatiC Encephalopathy (MASTERPIECE)

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Hepatic Encephalopathy, Cirrhosis

In brief

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.

Key facts

Study ID

NCT07528690

Run by

VA Office of Research and Development

People needed

162

Starts

2026-10-30

Expected to finish

2031-03-03

Last updated by the study team

2026-04-14

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 21 years of age
• Cirrhosis diagnosed by any of the following in a patient with chronic liver disease
• Liver Biopsy
• Radiologic evidence of varices, cirrhosis or portal hypertension
• Laboratory evidence of platelet count <110,000 or AST/ALT ratio>1
• Endoscopic evidence of varices or portal hypertensive gastropathy
• Prior overt HE (patient can be on lactulose and/or rifaximin 4 weeks stable dosing)
• Able to give written, informed consent [mini-mental status exam (MMSE)]>25 at the time of consenting)
• For lactulose only group: Prior HE not on rifaximin

You may not qualify if…

• Disease-related:
• MELD3.0 score>22
• WBC count<1000
• non-elective hospitalization or overt HE episode within 1 month
• on dialysis
• known untreated, luminal GI cancer
• chronic intrinsic GI diseases (ulcerative colitis, Crohn's disease, microscopic colitis, eosinophilic gastroenteritis or celiac disease)
• Safety-related:
• Current dysphagia
• History of aspiration, intestinal obstruction or non-medication induced gastroparesis
• Ongoing absorbable antibiotic use
• History of anaphylactic food allergy
• Allergy to ingredients in the capsules (glycerol, sodium chloride, hypromellose, gellan gum, titanium dioxide, theobroma oil)
• Adverse event attributable to prior FMT (7) ASA Class V
• Pregnant or nursing patients
• Acute illness or fever on the day of planned FMT
• History of spontaneous bacterial peritonitis

Where it is running

• CERC (VISN1, West Haven, CT) — West Haven, Connecticut, United States
• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States
• Richmond VA Medical Center, Richmond, VA — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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