Back to resultsFecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
Primary Purpose
Hepatic Encephalopathy
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Fecal Microbiota Transplant
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Encephalopathy
Eligibility Criteria
Inclusion Criteria:
- 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
- abnormal inhibitory control test, defined as greater than 5 lures.
- an infectious etiology which may cause HE has been ruled out
Exclusion Criteria:
- those with tense ascites
- those who do not provide assent
- those who are judged to have a life expectancy of less than 3 months,
- those who had TIPS within 3 months,
- those with neurologic diseases such as dementia, Parkinson's disease, and structural brain lesions
- pregnancy
- those with intestinal obstruction
- those with alcoholic hepatitis
- those with active alcohol or substance abuse
- those without stable social support
- those who have a concurrent infection, such as SBP, pneumonia or UTI
- those with creatinine clearance less than 50% compared to baseline
- those with recent hospital admission, defined as within one month of enrollment, for hepatic encephalopathy
Sites / Locations
- University of Alberta Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fecal Microbiota Transplant
Arm Description
Single arm open label FMT administered at Week 0 by colonoscopy and at Weeks 1-4 by enema
Outcomes
Primary Outcome Measures
Portion of participants with normailzation of ICT or Stroop Test during the study
Secondary Outcome Measures
Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8
Changes in serum ammonia level pre and post FMT
Changes in Quality of Life measured by Chronic Liver Disease Questionnaire (CDLQ) pre and post FMT
Changes in Intestinal Microbiota pre and post FMT
Serious Adverse Events
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.
Changes in stool bile acids composition pre and post FMT
Changes in stool short chain fatty acids pre and post FMT
Full Information
NCT ID
NCT02255617
First Posted
August 26, 2014
Last Updated
September 27, 2021
Sponsor
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT02255617
Brief Title
Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
Official Title
A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 23, 2014 (Actual)
Primary Completion Date
July 25, 2019 (Actual)
Study Completion Date
September 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alberta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fecal Microbiota Transplant
Arm Type
Experimental
Arm Description
Single arm open label FMT administered at Week 0 by colonoscopy and at Weeks 1-4 by enema
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiota Transplant
Intervention Description
Fecal transplant processed from routinely screened universal donors
Primary Outcome Measure Information:
Title
Portion of participants with normailzation of ICT or Stroop Test during the study
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients with normalization ICT or Stroop test scores at 1 week, 2 weeks, 4 weeks and 8
Time Frame
8 weeks
Title
Changes in serum ammonia level pre and post FMT
Time Frame
8 weeks
Title
Changes in Quality of Life measured by Chronic Liver Disease Questionnaire (CDLQ) pre and post FMT
Time Frame
8 weeks
Title
Changes in Intestinal Microbiota pre and post FMT
Time Frame
8 weeks
Title
Serious Adverse Events
Description
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
Title
Changes in stool bile acids composition pre and post FMT
Time Frame
8 Weeks
Title
Changes in stool short chain fatty acids pre and post FMT
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
abnormal inhibitory control test, defined as greater than 5 lures.
an infectious etiology which may cause HE has been ruled out
Exclusion Criteria:
those with tense ascites
those who do not provide assent
those who are judged to have a life expectancy of less than 3 months,
those who had TIPS within 3 months,
those with neurologic diseases such as dementia, Parkinson's disease, and structural brain lesions
pregnancy
those with intestinal obstruction
those with alcoholic hepatitis
those with active alcohol or substance abuse
those without stable social support
those who have a concurrent infection, such as SBP, pneumonia or UTI
those with creatinine clearance less than 50% compared to baseline
those with recent hospital admission, defined as within one month of enrollment, for hepatic encephalopathy
Facility Information:
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study
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