Fecal Transplant for Hepatic Encephalopathy

University of Alberta

Status and phase

Completed

Phase 2

Phase 1

Conditions

Hepatic Encephalopathy

Treatments

Biological: FMT

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03439982

Pro00060782

Details and patient eligibility

About

The purpose of the study is to determine if fecal microbiota transplant (FMT) can reverse hepatic encephalopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulose and/or rifaximin or metronidazole.

Full description

Subjects receive FMT from a single donor by colonoscopy at week 0 and by enema at weeks 1-4. HE is measured by Inhibitory Control Test (ICT) and Stroop test as well as fasting serum ammonia levels.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult cirrhotic patients of various etiology on lactulose and/pr rifaximin or metronidazole for minimum 4 weeks as secondary prophylaxis
Abnormal ICT (>5 lures) or abnormal Stroop test (>200 seconds)
Baseline Conn score 0 or 1
Infectious etiology of HE has been ruled out

Exclusion criteria

those with tense ascites
those who do not provide assent
life expectancy <3 months
TIPS within the past 3 months
neurologic disease such as dementia, Parkinson's, structural brain lesions
pregnancy
intestinal obstruction
alcoholic hepatitis
active alcohol or substance abuse
those without stable social support
concurrent infection such as spontaneous bacterial peritonitis, pneumonia or urinary tract infection
creatinine clearance less that 50% compared to baseline
hospital admission for HE within one month of enrollment
active hepatocellular carcinoma
active GI bleed