Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
NCT ID: NCT02255617
Last Updated: 2021-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
4 participants
INTERVENTIONAL
2014-07-23
2019-09-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fecal Microbiota Transplant
Single arm open label FMT administered at Week 0 by colonoscopy and at Weeks 1-4 by enema
Fecal Microbiota Transplant
Fecal transplant processed from routinely screened universal donors
Interventions
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Fecal Microbiota Transplant
Fecal transplant processed from routinely screened universal donors
Eligibility Criteria
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Inclusion Criteria
2. abnormal inhibitory control test, defined as greater than 5 lures.
3. an infectious etiology which may cause HE has been ruled out
Exclusion Criteria
2. those who do not provide assent
3. those who are judged to have a life expectancy of less than 3 months,
4. those who had TIPS within 3 months,
5. those with neurologic diseases such as dementia, Parkinson's disease, and structural brain lesions
6. pregnancy
7. those with intestinal obstruction
8. those with alcoholic hepatitis
9. those with active alcohol or substance abuse
10. those without stable social support
11. those who have a concurrent infection, such as SBP, pneumonia or UTI
12. those with creatinine clearance less than 50% compared to baseline
13. those with recent hospital admission, defined as within one month of enrollment, for hepatic encephalopathy
18 Years
65 Years
ALL
No
Sponsors
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University of Alberta
OTHER
Responsible Party
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Dina Kao
Assistant Professor
Locations
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University of Alberta Hospital
Edmonton, Alberta, Canada
Countries
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Other Identifiers
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47057
Identifier Type: -
Identifier Source: org_study_id
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