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Fecal Microbiota Transplantation (FMT) in the Management of Hepatic Encephalopathy (HE): a Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02255617
Recruitment Status : Recruiting
First Posted : October 2, 2014
Last Update Posted : June 6, 2018
Information provided by (Responsible Party):
Dina Kao, University of Alberta

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.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Biological: Fecal Microbiota Transplant Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Fecal Microbiota Transplant
Single arm open label FMT administered at Week 0 by colonoscopy and at Weeks 1-4 by enema
Biological: Fecal Microbiota Transplant
Fecal transplant processed from routinely screened universal donors

Primary Outcome Measures :
  1. Time to hepatic encephalopathy breakthrough [ Time Frame: 6 months ]
    duration from FMT to overt hepatic encephalopathy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02255617

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Contact: Dina Kao, MD 780 492 8307

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Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Principal Investigator: Dina Kao, MD         
Sponsors and Collaborators
University of Alberta

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Responsible Party: Dina Kao, Assistant Professor, University of Alberta Identifier: NCT02255617     History of Changes
Other Study ID Numbers: 47057
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
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Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases