Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study

University of Alberta

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hepatic Encephalopathy

Treatments: Biological: Fecal Microbiota Transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT02255617

47057

Details and patient eligibility

About

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 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 and Stroop as well as serum ammonia levels.

Enrollment: 4 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
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

1. those with tense ascites
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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Fecal Microbiota Transplant

Experimental group

Description:

Single arm open label FMT administered at Week 0 by colonoscopy and at Weeks 1-4 by enema

Treatment:

Biological: Fecal Microbiota Transplant