Fecal Transplant for Hepatic Encephalopathy

University of Alberta3 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatic Encephalopathy

Interventions

FMTBIOLOGICAL

FMT processed from routinely screened donors

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

Portion of participants with normalization of ICT or Stroop Test during the study

Time frame: 8 weeks

Secondary Outcomes

Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8

Time frame: 8 weeks

Changes in serum ammonia level pre and post FMT

Time frame: 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

Time frame: 8 weeks

Change in Intestinal Microbiota pre-and post FMT

Time frame: 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.

Time frame: 8 weeks

Change in stool Bile Acids Composition pre and post FMT

Time frame: 8 Weeks

Data from ClinicalTrials.gov

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