Status:
ACTIVE_NOT_RECRUITING
Fecal Microbiota Transplant as Treatment of Hepatic Encephalopathy
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Center for Microbiome Informatics and Therapeutics
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Decades of investigation demonstrate that hepatic encephalopathy (HE), a common complication of cirrhosis characterized by impaired cognition, develops as a consequence of intestinal microbial product...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03420482
Start Date
April 1 2018
End Date
January 31 2027
Last Update
December 31 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114