Fecal Transplant for Hepatic Encephalopathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Single Center Open Label Trial of RBX2660 (Microbiota Suspension) in the Management of Hepatic Encephalopathy

Conditions
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Hepatic Encephalopathy

Intervention / Treatment
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* Biological: FMT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT<br>Open label FMT administered at week 0 by colonoscopy and weeks 1-4 by enema | Biological: FMT<br>* FMT processed from routinely screened donors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Portion of participants with normalization of ICT or Stroop Test during the study |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8 |  | 8 weeks | 
| 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 | 29 Questions Total- each question is on a seven point scales, ranging from the worst (1) to the best (7) possible function | 8 weeks | 
| Change in Intestinal Microbiota pre-and post FMT |  | 8 weeks | 
| Serious Adverse Events | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic encephalopathy, fecal microbiota transplant