Status:
COMPLETED
Fecal Transplant for Hepatic Encephalopathy
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Rebiotix Inc.
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 mai...
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 12 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03439982
Start Date
April 12 2016
End Date
March 18 2021
Last Update
June 10 2022
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada