Status:
COMPLETED
Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
Lead Sponsor:
University of Alberta
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if FMT can reverse Hepatic Encephlopathy (HE) in cirrhotic patients who continue to have breakthrough episodes of HE despite maintenance therapy with lactulos...
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 and Stroop as well as serum ammonia levels.
Eligibility Criteria
Inclusion
- adult (age \> 18 years of age) cirrhotic patients of various etiology, on lactulose and/or rifaximin or flagyl for at least 4 weeks as secondary prophylaxis
- abnormal inhibitory control test, defined as greater than 5 lures.
- an infectious etiology which may cause HE has been ruled out
Exclusion
- those with tense ascites
- those who do not provide assent
- those who are judged to have a life expectancy of less than 3 months,
- those who had TIPS within 3 months,
- those with neurologic diseases such as dementia, Parkinson's disease, and structural brain lesions
- pregnancy
- those with intestinal obstruction
- those with alcoholic hepatitis
- those with active alcohol or substance abuse
- those without stable social support
- those who have a concurrent infection, such as SBP, pneumonia or UTI
- those with creatinine clearance less than 50% compared to baseline
- those with recent hospital admission, defined as within one month of enrollment, for hepatic encephalopathy
Key Trial Info
Start Date :
July 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02255617
Start Date
July 23 2014
End Date
September 23 2019
Last Update
October 4 2021
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada