Microbiota trAnSplant ThERaPy In hEpatiC Encephalopathy (MASTERPIECE)

Who can take part

• 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

Who cannot take part

• Adverse event attributable to prior FMT (7) ASA Class V
• Acute illness or fever on the day of planned FMT
• History of spontaneous bacterial peritonitis
• 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)
• Pregnant or nursing patients