Hepatic Encephalopathy
Conditions
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 lactulose and/or rifaximin or metronidazole.
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.
Interventions
BIOLOGICALFecal Microbiota Transplant
Fecal transplant processed from routinely screened universal donors
Sponsors
University of Alberta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Portion of participants with normailzation of ICT or Stroop Test during the study | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in serum ammonia level pre and post FMT | 8 weeks | — |
| Changes in Quality of Life measured by Chronic Liver Disease Questionnaire (CDLQ) pre and post FMT | 8 weeks | — |
| Changes in Intestinal Microbiota pre and post FMT | 8 weeks | — |
| Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8 | 8 weeks | — |
| Changes in stool bile acids composition pre and post FMT | 8 Weeks | — |
| Changes in stool short chain fatty acids pre and post FMT | 8 weeks | — |
| Serious Adverse Events | 8 weeks | All serious adverse events up to and including week 8. A serious adverse event is any event which results in any of the following: i) Death ii) Colonic perforation iii) Proven infections as defined by the presence of i) spontaneous bacteremia: positive blood cultures in the absence of any other potential source of infection; ii) spontaneous bacterial peritonitis: ascetic fluid PMN equal to or greater than 250/mm3; iii) UTI: urinary leukocyte count greater than 15 cells per HPF and positive urine culture; vi) other infections identified by clinical, radiologic and bacteriologic results. iv) Possible infections as defined by i) fever (temp \> 37.80 C), ii) leukocytosis (\>15,000 mm3) or increased immature neutrophils in blood (\>500 mm3), negative cultures and no other signs of infection. |
Countries
Canada
Outcome results
None listed