Hepatic Encephalopathy
Conditions
Keywords
Hepatic encephalopathy, fecal microbiota transplant
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 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 (ICT) and Stroop test as well as fasting serum ammonia levels.
Interventions
BIOLOGICALFMT
FMT processed from routinely screened donors
Sponsors
Rebiotix Inc.
University of Alberta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Portion of participants with normalization 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 | 29 Questions Total- each question is on a seven point scales, ranging from the worst (1) to the best (7) possible function |
| Change 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 | — |
| Change in stool Bile Acids Composition pre and post FMT | 8 Weeks | — |
| Changes in stool short chain free fatty acids pre and post FMT | 8 weeks | — |
| Serious Adverse Events | 8 weeks | i) 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