Microbiota trAnSplant ThERaPy In hEpatiC Encephalopathy (MASTERPIECE)
United States162 participantsStarted 2026-10-30
Plain-language summary
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 can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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