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ACTIVE NOT RECRUITING

NCT03420482

PHASE2

Fecal Microbiota Transplant as Treatment of Hepatic Encephalopathy

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

Summary

A common complication of advanced liver disease is a condition called hepatic encephalopathy, which leads to confusion. The current treatment options cause side effects, are costly, and do not always work. An abnormal population of bacteria in the intestines may be causing this condition, and transplanting bacteria from the colon of a healthy person may treat it. In this research study, the investigators will first find two healthy stool donors whose stool donation improves the gut bacteria of patients with advanced liver disease and helps them think more clearly. Then, in a randomized controlled trial, the investigators will compare the ability of stool donation from these two best donors versus a placebo to improve the neurological function of patients with advanced liver disease. If the investigators find the expected results, there will be a new effective therapy for patients with advanced liver disease and the very troublesome complication of hepatic encephalopathy.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2018-04-01

Completion Date

2027-01-31

Last Updated

2025-12-31

Healthy Volunteers

Conditions

Hepatic Encephalopathy

Interventions

DRUG

Fecal Microbiota Transplant (FMT) oral capsules

Donors will be healthy individuals, selected through a previously published, rigorous screening process. Elizabeth Hohmann M.D. of MGH has demonstrated the safety and therapeutic efficacy of oral frozen FMT capsules in Clostridium difficile infection, and her lab will produce the capsules for this study.

DRUG

Placebo oral capsule

Oral placebo capsules filled with glycerol and cocoa powder. These capsules are identical in appearance to FMT capsules.

Inclusion Criteria: * Diagnosis of cirrhosis: Based on liver biopsy or clinical assessment of a hepatologist based on history, exam, laboratory and radiographic evidence * History of at least one episode of overt HE, defined by West Haven Criteria Grades II to IV; episodes of HE that were precipitated by gastrointestinal hemorrhage requiring transfusion of at least 2 units of blood, by medication use, by renal failure requiring dialysis, or by injury to the central nervous system will not be counted as previous HE episodes * Compliant with lactulose and rifaximin treatment (lactulose: at least one dose at least 5 days per week; rifaximin: at least one dose at least 5 days per week) Exclusion Criteria: * Current episode of overt HE as defined by West Haven Criteria Grades II to IV * Expectation of liver transplantation within two months of the screening visit * Current infection * Variceal bleeding in the last 4 weeks * Gut-absorbable or intravenous antibiotic therapy (including ciprofloxacin for SBP prophylaxis) in the last 3 months * Alcohol or illicit drug intake within 3 months, by history and available serum testing; alcohol use will be characterized as \>1 alcoholic drink / month * PSC as etiology of liver disease, as prior literature has suggested these individuals have a unique microbiome * History of Roux-en-Y Gastric bypass * On immunosuppressive medications * Positive C. difficile test * Scoring above a threshold cut-off on the Psychometric Hepatic Encephalopathy Score (PHES) * MELD \> 17 * History of spontaneous bacterial peritonitis * History of low ascites protein ( ≤ 1g/dL) in the last year * Hemodialysis in the last 30 days * Other significant laboratory abnormalities: serum creatinine \> 2.0 mg/dL, hemoglobin \< 8 g/dL, serum sodium \< 125 mmol/L, serum calcium \> 11.0 mg/dL, serum potassium \< 2.5 mmol/L * Placement of a portosystemic shunt or transjugular intrahepatic portosystemic shunt * Unstable doses of opiates, benzodiazepines or other sedating medication * Unable to provide consent; a. If MMSE is \< 18 or the patient is deemed to not have capacity by an investigator, a legally authorized representative (surrogate) will be allowed to provide consent

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States